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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