BD ULTRA-FINE II INSULIN SYRINGE
Report
- Report Number
- 2243072-2019-00840
- Event Type
- Malfunction
- Date Received
- May 2, 2019
- Date of Event
- April 18, 2019
- Report Date
- May 16, 2019
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- PMA / PMN Number
- UNKNOWN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION SUMMARY: LEVEL A INVESTIGATION. COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT FOR FOREIGN MATTER (COMING OUT OF NEEDLE TIP) ON LOT # 8113511. INVESTIGATION SUMMARY: CUSTOMER RETURNED (4) LOOSE 3/10CC, 6MM SYRINGES. CUSTOMER STATES THAT THERE IS SOME "LIQUID" TYPE SUBSTANCE COMING OUT OF THE TIP ON A FEW SYRINGES. ALL RETURNED SYRINGES WERE TESTED AND ALL EXHIBITED A SMALL AMOUNT OF LIQUID COMING OUT OF THE CANNULA WHEN THE PLUNGER ROD WAS FULLY DEPRESSED. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. SAMPLES WILL BE FORWARDED TO MANUFACTURING (HOLDREGE) ON 17MAY2019 FOR FURTHER REVIEW. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. THE SILICONE APPLICATION PROCESS IS DESIGNED TO PROVIDE AN EVEN DISTRIBUTION OF SILICONE ON THE INTERIOR OF THE SYRINGE BARREL. WHEN THE PLUNGER IS FULLY DEPRESSED, THE SILICONE GETS DISTRIBUTED ALONG THE BARREL ROOF AND WALLS, ENSURING A LUBRICATED SURFACE FOR THE PLUNGER TO MOVE AGAINST. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF 25 BILLION UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. CAPA # 56537 AND SITUATION ANALYSIS # BDDC-16-871-SA HAVE BEEN OPENED TO ADDRESS THIS ISSUE A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8113511. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE THREE (3) NOTIFICATIONS (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: POSSIBLE ROOT CAUSES FOR EXCESS SILICONE INCLUDE: THE FIRST IS THAT SOME ASSOCIATES DO NOT DEGAS THE SILICONE AFTER REFILLING THE TANKS. SECOND, THE SILICONE VOLUME ON THE PUMP IS A PARAMETER THAT IS BEING ADJUSTED, BUT IS NOT UNDERSTOOD AND COULD BE A POTENTIAL KPIV. CAPA # 56537 AND SITUATION ANALYSIS # BDDC-16-871-SA HAVE BEEN OPENED TO ADDRESS THIS ISSUE.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD ULTRA-FINE¿ II INSULIN SYRINGE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN, BATCH NO: UNKNOWN. PLEASE SEE TW # (B)(4) FOR SAME EVENT, BUT A DIFFERENT DATE OF OCCURRENCE. PER SNOW UPDATE, THE CONSUMER FACED WITH THE SAME ISSUE YESTERDAY 04/18. UPDATED VERBATIM PER SNOW: FROM PHONE CALL ON 2019-04-18 14:06:49: CONSUMER PROVIDED LOT: 8113511, EXPIRATION DATE: 2023-05. STATED HE HAD THE SAME ISSUE TODAY FROM SAME LOT NUMBER AND IF HE GETS ANYMORE, HE WILL INCLUDE THEM IN THE MAIL KIT. IT WAS REPORTED THAT THE CONSUMER NOTICED SOME "LIQUID" TYPE SUBSTANCE COMING OUT OF THE TIP ON A FEW SYRINGES VERBATIM: EMAIL SENT 2019-04-11 16:18:29: I'VE BEEN A TYPE 1 DIABETIC FOR APPROXIMATELY 25 YEARS AND HAVE ALWAYS BEEN USING BD SYRINGES. I CURRENTLY USE 3/10ML 6MM 31G SYRINGES AND NOW I HAVE ENCOUNTERED SOMETHING THAT HAS NEVER HAPPENED BEFORE. BEFORE I ADMINISTER MY DOSE, I ALWAYS DEPRESS THE PLUNGER TO MAKE SURE ALL THE AIR IS OUT OF THE SYRINGE BEFORE I INSERT INTO THE INSULIN BOTTLE. TODAY, WHILE DEPRESSING THE PLUNGER, I NOTICED SOME "LIQUID" TYPE SUBSTANCE COMING OUT OF THE TIP ON A FEW SYRINGES (WHICH I MADE SURE THAT I DO NOT USE). THIS ONLY OCCURS WHEN THE SYRINGE ALREADY HAD SOME INSULIN BEFORE SO THIS IS A MYSTERY AND I AM A LITTLE WORRIED. I HAD ABOUT 5 SYRINGES DO THIS TODAY. D.1. MEDICAL DEVICE BRAND NAME: BD ULTRA-FINE¿ II INSULIN SYRINGE. D.2. MEDICAL DEVICE CATALOG #: 324919. D.2. UNIQUE IDENTIFIER (UDI) #: (B)(4). D.3. MEDICAL DEVICE MANUFACTURER: HOLDREGE. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. D.4. MEDICAL DEVICE LOT #: 8113511. G.1. MANUFACTURING LOCATION: HOLDREGE. H.4. DEVICE MANUFACTURE DATE: 2018-04-23.
IT WAS REPORTED THAT BD ULTRA-FINE¿ II INSULIN SYRINGE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN, BATCH NO: UNKNOWN. PLEASE SEE TW # (B)(4) FOR SAME EVENT, BUT A DIFFERENT DATE OF OCCURRENCE PER SNOW UPDATE, THE CONSUMER FACED WITH THE SAME ISSUE YESTERDAY 04/18 UPDATED VERBATIM PER SNOW: FROM PHONE CALL ON 2019-04-18 14:06:49: CONSUMER PROVIDED LOT: 8113511, EXPIRATION DATE: 2023-05. STATED HE HAD THE SAME ISSUE TODAY FROM SAME LOT NUMBER AND IF HE GETS ANYMORE, HE WILL INCLUDE THEM IN THE MAIL KIT. IT WAS REPORTED THAT THE CONSUMER NOTICED SOME "LIQUID" TYPE SUBSTANCE COMING OUT OF THE TIP ON A FEW SYRINGES. VERBATIM: EMAIL SENT¿2019-04-11 16:18:29. I'VE BEEN A TYPE 1 DIABETIC FOR APPROXIMATELY 25 YEARS AND HAVE ALWAYS BEEN USING BD SYRINGES. I CURRENTLY USE 3/10ML 6MM 31G SYRINGES AND NOW I HAVE ENCOUNTERED SOMETHING THAT HAS NEVER HAPPENED BEFORE. BEFORE I ADMINISTER MY DOSE, I ALWAYS DEPRESS THE PLUNGER TO MAKE SURE ALL THE AIR IS OUT OF THE SYRINGE BEFORE I INSERT INTO THE INSULIN BOTTLE. TODAY, WHILE DEPRESSING THE PLUNGER, I NOTICED SOME "LIQUID" TYPE SUBSTANCE COMING OUT OF THE TIP ON A FEW SYRINGES (WHICH I MADE SURE THAT I DO NOT USE). THIS ONLY OCCURS WHEN THE SYRINGE ALREADY HAD SOME INSULIN BEFORE SO THIS IS A MYSTERY AND I AM A LITTLE WORRIED. I HAD ABOUT 5 SYRINGES DO THIS TODAY.
IT WAS REPORTED THAT BD ULTRA-FINE¿ II INSULIN SYRINGE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. PLEASE SEE TW # (B)(4) FOR SAME EVENT, BUT A DIFFERENT DATE OF OCCURRENCE. PER SNOW UPDATE, THE CONSUMER FACED WITH THE SAME ISSUE YESTERDAY 04/18. UPDATED VERBATIM PER SNOW: FROM PHONE CALL ON 2019-04-18 14:06:49: CONSUMER PROVIDED LOT: 8113511, EXPIRATION DATE: 2023-05. STATED HE HAD THE SAME ISSUE TODAY FROM SAME LOT NUMBER AND IF HE GETS ANYMORE, HE WILL INCLUDE THEM IN THE MAIL KIT. IT WAS REPORTED THAT THE CONSUMER NOTICED SOME "LIQUID" TYPE SUBSTANCE COMING OUT OF THE TIP ON A FEW SYRINGES VERBATIM: EMAIL SENT 2019-04-11 16:18:29: I'VE BEEN A TYPE 1 DIABETIC FOR APPROXIMATELY 25 YEARS AND HAVE ALWAYS BEEN USING BD SYRINGES. I CURRENTLY USE 3/10ML 6MM 31G SYRINGES AND NOW I HAVE ENCOUNTERED SOMETHING THAT HAS NEVER HAPPENED BEFORE. BEFORE I ADMINISTER MY DOSE, I ALWAYS DEPRESS THE PLUNGER TO MAKE SURE ALL THE AIR IS OUT OF THE SYRINGE BEFORE I INSERT INTO THE INSULIN BOTTLE. TODAY, WHILE DEPRESSING THE PLUNGER, I NOTICED SOME "LIQUID" TYPE SUBSTANCE COMING OUT OF THE TIP ON A FEW SYRINGES (WHICH I MADE SURE THAT I DO NOT USE). THIS ONLY OCCURS WHEN THE SYRINGE ALREADY HAD SOME INSULIN BEFORE SO THIS IS A MYSTERY AND I AM A LITTLE WORRIED. I HAD ABOUT 5 SYRINGES DO THIS TODAY.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: LEVEL A INVESTIGATION. - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK DUE TO UNKNOWN LOT NUMBER. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. UNABLE TO PERFORM DHR CHECK DUE TO UNKNOWN LOT NUMBER. INVESTIGATION CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.
IT WAS REPORTED THAT UNSPECIFIED BD¿ SYRINGE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN, BATCH NO: UNKNOWN. PLEASE SEE (B)(4) FOR SAME EVENT, BUT A DIFFERENT DATE OF OCCURRENCE PER (B)(4) UPDATE, THE CONSUMER FACED WITH THE SAME ISSUE YESTERDAY (B)(6). UPDATED VERBATIM PER (B)(4): FROM PHONE CALL ON (B)(6) 2019 14:06:49: CONSUMER PROVIDED LOT: 8113511, EXPIRATION DATE: 2023-05. STATED HE HAD THE SAME ISSUE TODAY FROM SAME LOT NUMBER AND IF HE GETS ANYMORE, HE WILL INCLUDE THEM IN THE MAIL KIT. IT WAS REPORTED THAT THE CONSUMER NOTICED SOME "LIQUID" TYPE SUBSTANCE COMING OUT OF THE TIP ON A FEW SYRINGES VERBATIM: EMAIL SENT (B)(6) 2019 16:18:29: I'VE BEEN A TYPE 1 DIABETIC FOR APPROXIMATELY 25 YEARS AND HAVE ALWAYS BEEN USING BD SYRINGES. I CURRENTLY USE 3/10ML 6MM 31G SYRINGES AND NOW I HAVE ENCOUNTERED SOMETHING THAT HAS NEVER HAPPENED BEFORE. BEFORE I ADMINISTER MY DOSE, I ALWAYS DEPRESS THE PLUNGER TO MAKE SURE ALL THE AIR IS OUT OF THE SYRINGE BEFORE I INSERT INTO THE INSULIN BOTTLE. TODAY, WHILE DEPRESSING THE PLUNGER, I NOTICED SOME "LIQUID" TYPE SUBSTANCE COMING OUT OF THE TIP ON A FEW SYRINGES (WHICH I MADE SURE THAT I DO NOT USE). THIS ONLY OCCURS WHEN THE SYRINGE ALREADY HAD SOME INSULIN BEFORE SO THIS IS A MYSTERY AND I AM A LITTLE WORRIED. I HAD ABOUT 5 SYRINGES DO THIS TODAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 369513 | BD ULTRA-FINE II INSULIN SYRINGE | SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 8113511 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |