BD 1ML LUER-LOK¿ SYRINGE
Report
- Report Number
- 1213809-2022-00003
- Event Type
- Malfunction
- Date Received
- January 18, 2022
- Date of Event
- December 23, 2021
- Report Date
- January 25, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS WHICH MAY HAVE BEEN INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0059908. MEDICAL DEVICE EXPIRATION DATE: 2025-02-28. DEVICE MANUFACTURE DATE: 2020-03-01. MEDICAL DEVICE LOT #: 1043799 (INVALID LOT #). MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: NA. MEDICAL DEVICE LOT #: 1127514. MEDICAL DEVICE EXPIRATION DATE: 2026-04-30. DEVICE MANUFACTURE DATE: 2021-05-20. MEDICAL DEVICE LOT #: 1146636 (INVALID LOT #S). MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: NA.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS WHICH MAY HAVE BEEN INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0059908. MEDICAL DEVICE EXPIRATION DATE: 2025-02-28. DEVICE MANUFACTURE DATE: 2020-03-01. MEDICAL DEVICE LOT #: 1043799 (INVALID LOT #). MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: NA. MEDICAL DEVICE LOT #: 1127514. MEDICAL DEVICE EXPIRATION DATE: 2026-04-30. DEVICE MANUFACTURE DATE: 2021-05-20. MEDICAL DEVICE LOT #: 1146636 (INVALID LOT #S). MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: NA.
H.6. INVESTIGATION: ONE PHOTO AND THREE LOOSE 1ML SYRINGES (P/N 309648) WERE RECEIVED AND EVALUATED. ALL SAMPLES HAD JAMMED STOPPERS/ INCORRECT STOPPER ANGULARITY. THE CONDITION OBSERVED WAS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT 3 BD 1ML LUER-LOK¿ SYRINGES EXPERIENCED MISALIGNED STOPPERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS RECEIVED 3 PIECES OF SYRINGES OF ITEM WHERE THE RUBBER OF THE PLUNGER IS DEFORMED.
IT WAS REPORTED THAT 3 BD 1ML LUER-LOK¿ SYRINGES EXPERIENCED MISALIGNED STOPPERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS RECEIVED 3 PIECES OF SYRINGES OF ITEM WHERE THE RUBBER OF THE PLUNGER IS DEFORMED.
IT WAS REPORTED THAT 3 BD 1ML LUER-LOK¿ SYRINGES EXPERIENCED MISALIGNED STOPPERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS RECEIVED 3 PIECES OF SYRINGES OF ITEM WHERE THE RUBBER OF THE PLUNGER IS DEFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 757710 | BD 1ML LUER-LOK¿ SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | SEE H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |