SYRINGE 0.3ML 31G 6MM HALF UNIT 10BAG CA
Report
- Report Number
- 2243072-2019-00784
- Event Type
- Malfunction
- Date Received
- April 25, 2019
- Date of Event
- April 11, 2019
- Report Date
- June 6, 2019
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. 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. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT SYRINGE 0.3ML 31G 6MM HALF UNIT 10BAG CA HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO: 324919 BATCH NO: 8113511. IT WAS REPORTED THAT THE CONSUMER NOTICED SOME "LIQUID" TYPE SUBSTANCE COMING OUT OF THE TIP ON A FEW SYRINGES VERBATIM: 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. EMAIL SENT (B)(6) 201916:18:29 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: SYRINGE 0.3ML 31G 6MM HALF UNIT 10BAG CA . 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: (B)(4). H.4. DEVICE MANUFACTURE DATE: 2018-04-23 .
H.6. INVESTIGATION: 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. CAPA # 56537 AND SITUATION ANALYSIS # (B)(4) 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 [200758384, 200758574, 200758319] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. 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.
IT WAS REPORTED THAT FOREIGN MATTER OCCURRED WITH A UNSPECIFIED BD SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO: UNKNOWN. BATCH NO: UNKNOWN. 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 A SYRINGE 0.3ML 31G 6MM HALF UNIT 10BAG CA HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO: 324919 BATCH NO: 8113511. IT WAS REPORTED THAT THE CONSUMER NOTICED SOME "LIQUID" TYPE SUBSTANCE COMING OUT OF THE TIP ON A FEW SYRINGES VERBATIM: 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. EMAIL SENT¿(B)(6) 201916:18:29 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."
DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT SYRINGE 0.3ML 31G 6MM HALF UNIT 10BAG CA HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO: 324919 BATCH NO: 8113511. IT WAS REPORTED THAT THE CONSUMER NOTICED SOME "LIQUID" TYPE SUBSTANCE COMING OUT OF THE TIP ON A FEW SYRINGES VERBATIM: 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. EMAIL SENT (B)(6) 201916:18:29 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."
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). DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT FOREIGN MATTER OCCURRED WITH A UNSPECIFIED BD SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN 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 |
|---|---|---|---|---|---|---|---|
| 343612 | SYRINGE 0.3ML 31G 6MM HALF UNIT 10BAG CA | SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 8113511 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |