1 ML BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE
Report
- Report Number
- 1213809-2021-00853
- Event Type
- Malfunction
- Date Received
- January 7, 2022
- Date of Event
- December 9, 2021
- Report Date
- December 21, 2021
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903095972
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9347549. MEDICAL DEVICE EXPIRATION DATE: 2024-11-30. DEVICE MANUFACTURE DATE: 2019-12-13. MEDICAL DEVICE LOT #: 0080940. MEDICAL DEVICE EXPIRATION DATE: 2020-03-20. DEVICE MANUFACTURE DATE: 2025-02-28. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. IT WAS FOUND THROUGH TECHNICIAN LOGS THAT THE NEEDLE NEST HAD BEEN ADJUSTED DURING PRODUCTION OF BATCH #9347549 ON ONE OF THE ASSEMBLY MACHINES WITH NO ADDITIONAL COMMENTS CONCERNING PRODUCT DEFECTS NOTED. ALL FORCE TESTS WERE PERFORMED AND YIELDED ACCEPTABLE RESULTS FOR THE COMPLAINT BATCHES. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBER 0080940 AND 9374549 THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED 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.
MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9347549. MEDICAL DEVICE EXPIRATION DATE: 2024-11-30. DEVICE MANUFACTURE DATE: 2019-12-13. MEDICAL DEVICE LOT #: 0080940. MEDICAL DEVICE EXPIRATION DATE: 2020-03-20. DEVICE MANUFACTURE DATE: 2025-02-28. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. IT WAS FOUND THROUGH TECHNICIAN LOGS THAT THE NEEDLE NEST HAD BEEN ADJUSTED DURING PRODUCTION OF BATCH #9347549 ON ONE OF THE ASSEMBLY MACHINES WITH NO ADDITIONAL COMMENTS CONCERNING PRODUCT DEFECTS NOTED. ALL FORCE TESTS WERE PERFORMED AND YIELDED ACCEPTABLE RESULTS FOR THE COMPLAINT BATCHES. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBER 0080940 AND 9374549 THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED 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.
IT WAS REPORTED THAT WHILE USING A 1 ML BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE THE NEEDLE SEPARATED FROM SYRINGE. THIS OCCURRED ONCE WITH BOTH LOTS REPORTED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT INDICATED NEEDLE AND SYRINGE SEPARATE WHERE THE NEEDLE WILL BE LEFT IN WHEN SHE PULLS THE SYRINGE OUT.
IT WAS REPORTED THAT WHILE USING A 1 ML BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE THE NEEDLE SEPARATED FROM SYRINGE. THIS OCCURRED ONCE WITH BOTH LOTS REPORTED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT INDICATED NEEDLE AND SYRINGE SEPARATE WHERE THE NEEDLE WILL BE LEFT IN WHEN SHE PULLS THE SYRINGE OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2517877 | 1 ML BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 309597 | SEE H10 | 30382903095972 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |