SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG
Report
- Report Number
- 1920898-2019-01008
- Event Type
- Malfunction
- Date Received
- September 19, 2019
- Date of Event
- September 4, 2019
- Report Date
- October 2, 2019
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00311917048154
- PMA / PMN Number
- K024112
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8204705, MEDICAL DEVICE EXPIRATION DATE: 2023-07-31, DEVICE MANUFACTURE DATE: 2018-07-23. MEDICAL DEVICE LOT #: 8141538, MEDICAL DEVICE EXPIRATION DATE: 2023-06-30, DEVICE MANUFACTURE DATE: 2018-05-21. MEDICAL DEVICE LOT #: 8043569, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2018-02-12. MEDICAL DEVICE LOT #: 8232713, MEDICAL DEVICE EXPIRATION DATE: 2023-08-31, DEVICE MANUFACTURE DATE: 2018-08-20. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
ADDITIONAL INFORMATION: THERE WAS AN ADDITIONAL LOT NUMBER REPORTED TO BE INVOLVED. THE INFORMATION FOR THE LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8351995; MEDICAL DEVICE EXPIRATION DATE: 1/31/2024; DEVICE MANUFACTURE DATE: 12/17/2018. INVESTIGATION SUMMARY: CUSTOMER RETURNED (32) LOOSE 31G X 8MM, 0.3ML (B)(6) INSULIN SYRINGES. CONSUMER REPORTED SYRINGES ARE VERY HARD TO CALCULATE THE READINGS OF 5 UNITS OR LESS ¿ CLAIMS THE BOTTOM MARKER IS ABOVE THE BARREL END AND SOMETIMES FINDS PLUNGER RESTS ABOVE THE LAST MARKER WITH A 1/4 UNIT OFF. ALL 32 RETURNED SYRINGES WERE EXAMINED, THEN TESTED USING A 0.3ML SYRINGE PLUG GAUGE: ALL 32 SYRINGES FELL WITHIN THE PLUG GAUGE SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8204705. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8141538. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED FOR SCRATCHED PRINT A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8043569 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8232713. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #8351995. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR MISSING PRINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -UNCONFIRMED: BD WAS NOT 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.
IT WAS REPORTED THAT THE SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG HAD SCALE MARKINGS THAT WERE DIFFICULT TO READ ON THE "5 UNIT" LINE AND BELOW. ADDITIONALLY, IT WAS REPORTED THAT THE BOTTOM MARKER WAS ABOVE THE BARREL END, AND THE PLUNGER WAS "1/4 UNIT" OFF ABOVE THE LAST SCALE MARKING. THE DEFECTS WERE FOUND DURING USE, AND THE SYRINGES WERE USED TO DISPENSE MEDICATION TO THE CONSUMER'S CAT. LOT #'S 8204705, 8141538, 8043569, AND 8232713 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PET OWNER FINDING SEVERAL BOXES SINCE NOVEMBER WHERE CALLER STATED THE SYRINGES ARE VERY HARD TO CALCULATE THE READINGS OF 5 UNITS OR LESS FOR HIS CAT. CLAIMS THE BOTTOM MARKER IS ABOVE THE BARREL END AND SOMETIMES FINDS PLUNGER RESTS ABOVE THE LAST MARKER WITH A 1/4 UNIT OFF. DISCARDED AND DID NOT USE THE QUESTIONABLE ONES ON HIS CAT."
IT WAS REPORTED THAT THE SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG HAD SCALE MARKINGS THAT WERE DIFFICULT TO READ ON THE "5 UNIT" LINE AND BELOW. ADDITIONALLY, IT WAS REPORTED THAT THE BOTTOM MARKER WAS ABOVE THE BARREL END, AND THE PLUNGER WAS "1/4 UNIT" OFF ABOVE THE LAST SCALE MARKING. THE DEFECTS WERE FOUND DURING USE, AND THE SYRINGES WERE USED TO DISPENSE MEDICATION TO THE CONSUMER'S CAT. LOT #'S 8204705, 8141538, 8043569, AND 8232713 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PET OWNER FINDING SEVERAL BOXES SINCE NOVEMBER WHERE CALLER STATED THE SYRINGES ARE VERY HARD TO CALCULATE THE READINGS OF 5 UNITS OR LESS FOR HIS CAT. CLAIMS THE BOTTOM MARKER IS ABOVE THE BARREL END AND SOMETIMES FINDS PLUNGER RESTS ABOVE THE LAST MARKER WITH A 1/4 UNIT OFF. DISCARDED AND DID NOT USE THE QUESTIONABLE ONES ON HIS CAT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 889693 | SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | SEE SECTION H.10. | 00311917048154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |