BD 5ML SYRINGE LUER-LOK TIP
Report
- Report Number
- 1213809-2019-01330
- Event Type
- Malfunction
- Date Received
- January 3, 2020
- Date of Event
- December 19, 2019
- Report Date
- February 21, 2020
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903096498
- PMA / PMN Number
- K980987
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6 INVESTIGATION SUMMARY: EIGHT PHOTOS AND TWENTY-SEVEN 5ML SYRINGES IN BLISTER PACKS FROM BATCH 9246783 (P/N 309649) WERE RECEIVED AND EVALUATED. TWO SYRINGES WERE IN OPENED BLISTER PACKS AND TWENTY-FIVE WERE FULLY SEALED. IT WAS OBSERVED IN THE PHOTOS AND PHYSICAL SAMPLES THERE WAS A LINE EXTENDING FROM THE TIP TO THE TOP OF THE BARREL. IT APPEARED TO BE A SMALL AMOUNT OF EXTRA MATERIAL. THE FLASH OBSERVED EXTENDING FROM THE TIP OF THE SYRINGE TO THE TOP OF THE BARREL IS PART OF THE NORMAL MOLDING PROCESS. WHILE IT MAY APPEAR TO BE A CRACK, IT WAS A SMALL AMOUNT EXTRA MATERIAL THAT IS A RESULT OF FORMING THE THREAD OF THE SYRINGE. IT IS COSMETIC IN NATURE AND DOES NOT AFFECT THE FORM, FIT OR FUNCTION OF THE DEVICE. NO DEFECTS WERE OBSERVED IN THE SAMPLES OR PHOTOS RECEIVED. DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE THREE PROVIDED LOT NUMBER(S) THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT BD 5ML SYRINGE LUER-LOK¿ TIP HAD A CRACK. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YESTERDAY WE SPOTTED A DEFECT IN SOME OF OUR 5ML SYRINGES WHERE IT APPEARS THERE IS A HAIRLINE CRACK NEAR THE TOP OF THE SYRINGE, THIS DEFECT WAS FOUND WITHIN MULTIPLE BATCHES. WE HAVE PERFORM A VISUAL INSPECTION OF OUR CURRENT STOCK AND ALTHOUGH NOT EVERY SYRINGE WITHIN THESE BATCHES WAS AFFECTED, WE FOUND 30 SYRINGES WITH THIS POSSIBLE DEFECT (27 OF THESE HAS BEEN PLACED IN QUARANTINE).
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9200384, MEDICAL DEVICE EXPIRATION DATE: 2024-06-30, DEVICE MANUFACTURE DATE: 2019-07-19, MEDICAL DEVICE LOT #: 9246783, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-09-03, MEDICAL DEVICE LOT #: 9163895, MEDICAL DEVICE EXPIRATION DATE: 2024-05-31, DEVICE MANUFACTURE DATE: 2019-06-12. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BD 5ML SYRINGE LUER-LOK¿ TIP HAD A CRACK. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YESTERDAY WE SPOTTED A DEFECT IN SOME OF OUR 5ML SYRINGES WHERE IT APPEARS THERE IS A HAIRLINE CRACK NEAR THE TOP OF THE SYRINGE, THIS DEFECT WAS FOUND WITHIN MULTIPLE BATCHES. WE HAVE PERFORM A VISUAL INSPECTION OF OUR CURRENT STOCK AND ALTHOUGH NOT EVERY SYRINGE WITHIN THESE BATCHES WAS AFFECTED, WE FOUND 30 SYRINGES WITH THIS POSSIBLE DEFECT (27 OF THESE HAS BEEN PLACED IN QUARANTINE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12276 | BD 5ML SYRINGE LUER-LOK TIP | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 309649 | SEE H.10 | 30382903096498 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |