BD LUER-LOK¿ SYRINGE
Report
- Report Number
- 1213809-2021-00778
- Event Type
- Malfunction
- Date Received
- November 22, 2021
- Date of Event
- October 26, 2021
- Report Date
- December 20, 2021
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903095781
- PMA / PMN Number
- K980987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-12-08. D4: MEDICAL DEVICE LOT #: 1076679. D4: MEDICAL DEVICE EXPIRATION DATE: 2026-02-28. H4: DEVICE MANUFACTURE DATE: 2021-03-17. D4: MEDICAL DEVICE LOT #: 6062957. D4: MEDICAL DEVICE EXPIRATION DATE: 2021-02-28. H4: DEVICE MANUFACTURE DATE: 2016-03-02. INVESTIGATION SUMMARY: THIRTY-TWO 3ML SYRINGES (P/N 309578) SEALED IN THEIR BLISTER PACKAGES WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. TWENTY-EIGHT SAMPLES WERE FROM BATCH #0122568, TWO WERE FROM BATCH #1076679, AND TWO WERE FROM BATCH #6062957. THE SAMPLES WERE FOUND TO HAVE NO CRACKS OR VISIBLE DEFECTS PRESENT. BATCH #6062957 WAS EXPIRED AS OF FEBRUARY 2021 AND BD DOES NOT MAKE CLAIMS ABOUT THE PERFORMANCE OR EFFICACY OF EXPIRED PRODUCTS. SINCE THE SAMPLES RECEIVED DID NOT DISPLAY THE REPORTED CONDITION A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED, AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED BD LUER-LOK¿ SYRINGE WAS DAMAGED, CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECENTLY FOUND TROUBLE WITH A SPECIFIC LOT OF SYRINGES... WHERE THE SYRINGES HAVE A CRACK IN THEM. THIS IS DANGEROUS, AS WE FOUND WHEN A CRACK IN A SYRINGE CAUSED SOME MEDICATION TO SPRAY OUT...".
IT WAS REPORTED BD LUER-LOK¿ SYRINGE WAS DAMAGED, CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECENTLY FOUND TROUBLE WITH A SPECIFIC LOT OF SYRINGES... WHERE THE SYRINGES HAVE A CRACK IN THEM. THIS IS DANGEROUS, AS WE FOUND WHEN A CRACK IN A SYRINGE CAUSED SOME MEDICATION TO SPRAY OUT...".
IT WAS REPORTED BD LUER-LOK¿ SYRINGE WAS DAMAGED, CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECENTLY FOUND TROUBLE WITH A SPECIFIC LOT OF SYRINGES... WHERE THE SYRINGES HAVE A CRACK IN THEM. THIS IS DANGEROUS, AS WE FOUND WHEN A CRACK IN A SYRINGE CAUSED SOME MEDICATION TO SPRAY OUT...".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1754185 | BD LUER-LOK¿ SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 309578 | SEE H10 | 30382903095781 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |