THE WELCH COMPANY
440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700
rodwelch@pacbell.net


S U M M A R Y


DIARY: September 5, 2008 09:02 AM Friday; Rod Welch

Millie asks Bard about Huber needles and product defect Power Port.

1...Summary/Objective


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CONTACTS 

SUBJECTS
Bard Coordinating Plans Strategy with  Kiser for Next CT Test Avoid

0403 -
0403 -    ..
0404 - Summary/Objective
0405 -
040501 - Follow up ref SDS 9 0000. ref SDS 8 0000.
040502 -
040503 -
040504 -
040505 -
040506 -
040507 -
040509 -  ..
0406 -
0407 -
0408 - Progress
0409 -
040901 - On 080805 Steve...
040902 -
040903 -           Steve Sigl
040904 -           925 200 6419
040905 -           Bard
040906 -           District Manager
040907 -           steve.sigl@crbard.com
040908 -
040909 - ...planned to read the record, ref SDS 9 8495, of Millie's failed CT
040910 - test at Kaiser on 080718. ref SDS 5 0001  Steve also indicated he
040911 - would notify Bard management to follow up on company protocol to
040912 - investigate for product defects, which Steve presented during a call
040913 - the day before on 080804, ref SDS 8 4R40, and which was confirmed in a
040914 - letter to Steve later that day on 080804. ref SDS 8 CM5P
040916 -  ..
040917 - This morning, called Steve.  He had another call, and said he would
040918 - call back in 10 minutes.
040920 -  ..
040921 - About 20 minutes later, Millie was ready to go hiking, and then to the
040922 - hospital for Neupogen treatment.  Since Steve had not called back...
040924 -  ..
040925 - Millie submitted a letter to Steve at Bard saying...
040926 -
040927 -    1.  Subject: CT Test Scheduled for Kaiser Oakland Sep 11
040928 -        Date: Fri, 05 Sep 2008 09:07:59 -0700
040933 -         ..
040934 -    2.  Dear Steve,
040936 -         ..
040937 -    3.  Rod called this morning to notify Bard that I will have a CT
040938 -        test at Kaiser in Oakland next Thursday, 080911 1330, per my
040939 -        letter to Kaiser on 080903. ref SDS 10 BK5N
040941 -         ..
040942 -    4.  First, thanks again for your support and to Julie for helping
040943 -        Kaiser find a business unit with experience doing CT tests with
040944 -        the Bard Power Port.
040946 -         ..
040947 -    5.  As you know, on 080718 Kaiser in Walnut Creek tried
040948 -        unsuccessfully to do a CT test with the Bard Power port.
040949 -        ref SDS 5 LK3R
040951 -         ..
040952 -    6.  Bard was notified of this problem with respect to concerns
040953 -        about product defect, as shown in my letter to you on 080804.
040954 -        ref SDS 8 4S62
040956 -         ..
040957 -    7.  I assume that Bard's silence establishes that Bard has reviewed
040958 -        the record on 080718 and is satisfied events as described do
040959 -        not present a risk to me for doing the next CT test on 080911.
040961 -         ..
040962 -    8.  I asked Rod to call this morning to ask if the Angiodynamics
040963 -        Lifeguard Safety Needle which UCSF will use next week on 080911
040964 -        will present concerns for Bard as the Huber needle connection
040965 -        to inject contrast medium, as shown in the record on 080724.
040966 -        ref SDS 6 MV7Y
040968 -         ..
040969 -    9.  I assume this presents an identical connection to the Bard
040970 -        Powerloc Safety Infusion set specified in the Bard product
040971 -        documentation which I received from Kaiser on 080708 when the
040972 -        Power Power was implanted. ref SDS 2 JE7N
040974 -         ..
040975 -   10.  I am only concerned that the Kaiser CT technologist might
040976 -        encounter a different connection mechanics, and cause
040977 -        confusion.  I expect these are standardized, but just double
040978 -        checking.
040979 -
040980 -           [On 080911 Angela at CT Department with Kaiser in Oakland
040981 -           asked for Millie's Power Port ID card; after learning Millie
040982 -           has the Bard Power Port, she advised that training by Bard
040983 -           personnel a day or so earlier resolved issues, ref SDS 11
040984 -           JX60; and so did not need the Power Port ID card to check
040985 -           flow rates and flushing instructions, and did not need to
040986 -           change settings on CT test equipment; this resulted in
040987 -           successful CT test using Bard Power Port. ref SDS 11 LK3R
040989 -            ..
040990 -           [On 080912 Steve, District Manager for Bard, disclosed that
040991 -           he sent a representative to the Kaiser CT Department in
040992 -           Oakland a few days before Millie's test to provide training
040993 -           and orientation. ref SDS 12 C65I
040994 -
041001 -
041002 -
041004 -  ..
0411 -
0412 -
0413 - 1213
0414 -
041401 - When Millie returned from the hospital after her treatment, there was
041402 - a telephone message from Steve.  He apologized for not calling back in
041403 - 10 minutes, as planned earlier this morning, per above. ref SDS 0 Y78N
041405 -  ..
041406 - Steve said the other call lasted longer than expected.  By the time he
041407 - completed the call, he had forgotten about calling back on Millie's CT
041408 - test.
041410 -  ..
041411 - Steve related having received Millie's letter this morning, per above.
041412 - ref SDS 0 OU8G  He was in a hurry to leave for a meeting, or
041413 - something; he may have mentioned a conference call, but sent a letter
041414 - saying "yes" that Huber needles are standardized for connecting to CT
041415 - equipment to inject contrast medium, answering Millie's question, per
041416 - above. ref SDS 0 Y84R  After sending the letter, he decided to call
041417 - and leave a message to clarify his letter.
041418 -
041420 -  ..
0415 -
0416 -
0417 - 1311
0418 -
041801 - Millie received a letter from Steve answering Millie's letter to Bard,
041802 - per above. ref SDS 0 OU8G, and as noted in Steve's telephone message,
041803 - also above. ref SDS 0 4Q6R
041804 -
041805 -    1.  Subject:  RE: CT Test Scheduled for Kaiser Oakland Sep 11
041806 -        Date:  Fri, 5 Sep 2008 15:04:07 -0400
041810 -         ..
041811 -    2.  Millie and Rob
041813 -         ..
041814 -    3.  Yes, Kaiser Oakland only uses power loc needles in the CT area.
041816 -         ..
041817 -    4.  Let me know if I can be of more assistance.
041819 -  ..
041820 - Steve's letter was clarified by his telephone message, per above,
041821 - ref SDS 0 4Q7V, as responding to Millie's letter asking for Bard
041822 - assurance that the record in this case is okay for Millie to get
041823 - another CT test at Oakland. ref SDS 0 Y76S
041824 -
041826 -  ..
041827 - Bard's letter to Millie concludes...
041828 -
041836 -         ..
041837 -    5.  Confidentiality Notice:  This e-mail and any attachments are
041838 -        intended only for the use of those to whom it is addressed and
041839 -        may contain information that is confidential and prohibited
041840 -        from further disclosure under law. If you have received this
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041842 -        is strictly prohibited. If you are not the intended recipient,
041843 -        please contact the sender by reply e-mail and destroy all
041844 -        copies of the original message and any attachments.[v1.0]
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