BD LUER-LOK¿ SYRINGE
Report
- Report Number
- 8041187-2022-00067
- Event Type
- Malfunction
- Date Received
- February 4, 2022
- Date of Event
- January 21, 2022
- Report Date
- February 23, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL (SINGAPORE)
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1140582. MEDICAL DEVICE EXPIRATION DATE: 2026-05-31. DEVICE MANUFACTURE DATE: 2021-06-17. MEDICAL DEVICE LOT #: 1104061. MEDICAL DEVICE EXPIRATION DATE: 2026-04-30. DEVICE MANUFACTURE DATE: 2021-05-14. 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 REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1140582. MEDICAL DEVICE EXPIRATION DATE: 2026-05-31. DEVICE MANUFACTURE DATE: 2021-06-17. MEDICAL DEVICE LOT #: 1104061. MEDICAL DEVICE EXPIRATION DATE: 2026-04-30. DEVICE MANUFACTURE DATE: 2021-05-14. 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: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 2/11/2022. H.6. INVESTIGATION: ONE PHOTO AND ONE SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO AND SAMPLE, STOPPER POOR ASSEMBLY WAS OBSERVED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE PROBABLE ROOT CAUSE COULD BE THAT THE STOPPER WAS NOT PROPERLY SEATED ON THE LOWER TOOLING RESULTING IN THE NON-CONFORMANCE. THERE IS A VISION SYSTEM AT THE ASSEMBLY MACHINE WHICH CAN DETECT AND AUTO-REJECT SUCH NON-CONFORMANCE. THE RETURNED SAMPLE WAS CHALLENGED AT THE ASSEMBLY VISION SYSTEM AND ABLE TO BE REJECTED AT 180-DEGREE POINT OF VIEW. THEREFORE, THE NONCONFORMANCE COULD HAVE BEEN ESCAPEES RESULTING IT TO FLOW TO THE NEXT PROCESS.
IT WAS REPORTED THAT THE STOPPER PARTIALLY SEPARATED FROM THE BD LUER-LOK¿ SYRINGE PLUNGER, CAUSING IT TO GET STUCK AND FLUID TO LEAK PAST IT. THIS OCCURRED ONCE EACH IN LOTS 1140582 AND 1104061. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLUNGER GET STUCK IN THE TUBE, THIS CAUSE FLUID TO DRAIN OUT BY THE PLUNGER END OF THE SYRINGE."
IT WAS REPORTED THAT THE STOPPER PARTIALLY SEPARATED FROM THE BD LUER-LOK¿ SYRINGE PLUNGER, CAUSING IT TO GET STUCK AND FLUID TO LEAK PAST IT. THIS OCCURRED ONCE EACH IN LOTS 1140582 AND 1104061. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLUNGER GET STUCK IN THE TUBE, THIS CAUSE FLUID TO DRAIN OUT BY THE PLUNGER END OF THE SYRINGE."
IT WAS REPORTED THAT THE STOPPER PARTIALLY SEPARATED FROM THE BD LUER-LOK¿ SYRINGE PLUNGER, CAUSING IT TO GET STUCK AND FLUID TO LEAK PAST IT. THIS OCCURRED ONCE EACH IN LOTS 1140582 AND 1104061. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLUNGER GET STUCK IN THE TUBE, THIS CAUSE FLUID TO DRAIN OUT BY THE PLUNGER END OF THE SYRINGE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1235284 | BD LUER-LOK¿ SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL (SINGAPORE) | SEE SECTION H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |