BD® 10ML SYRINGE NRFIT¿ LOK (STERILE)
Report
- Report Number
- 1213809-2022-00649
- Event Type
- Malfunction
- Date Received
- September 28, 2022
- Date of Event
- September 8, 2022
- Report Date
- November 12, 2024
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- QEH
- UDI-DI
- 00382904001742
- PMA / PMN Number
- K192538
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS . INITIAL REPORTER NAME AND ADDRESS: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, (B)(6) WAS USED AS A PLACE HOLDER. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT SAMPLE HAD 10ML LUER LOCK STANDARD BARREL INSTEAD OF 10ML NRFIT LOCK BARREL. POTENTIAL ROOT CAUSE FOR THE MIXED PRODUCT DEFECT IS ASSOCIATED WITH INADEQUATE LINE CLEARANCE ON THE MARKING MACHINERY. A CORRECTIVE ACTION PROJECT WAS OPENED TO FURTHER INVESTIGATE THESE DEFECT. MANUFACTURING PERSONNEL WILL BE NOTIFIED OF THIS INCIDENT AND ADDITIONAL TRAINING WILL BE PROVIDED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1041220. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION WITH THE PHOTO ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED.
(B)(4). FOLLOW UP #2 REPORT FOR CORRECTION. THE EVENT/PRODUCT PROBLEM WAS INCORRECT IN THE INITIAL MDR. CORRECT EVENT/PRODUCT PROBLEM IS MIXED PRODUCT / LOTS. ANNEX A CODE WAS INCORRECT IN THE INITIAL MDR. ANNEX A CODE SHOULD BE A2101 - DEVICE MARKINGS / LABELING PROBLEM.
IT WAS REPORTED WHILE USING BD® 10ML SYRINGE NRFIT¿ LOK (STERILE) THE TIP OF THE LUER WAS DEFORMED. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR TESTING SITES INITIALLY BELIEVED THE NRFIT SYRINGES TO BE INCOMPATIBLE WITH THE NRFIT NEEDLES; HOWEVER UPON CLOSER INSPECTION THEY CONFIRMED THE NRFIT SYRINGE CONTAINED A DEFECT.
IT WAS REPORTED WHILE USING BD® 10ML SYRINGE NRFIT¿ LOK (STERILE) THE TIP OF THE LUER WAS DEFORMED. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR TESTING SITES INITIALLY BELIEVED THE NRFIT SYRINGES TO BE INCOMPATIBLE WITH THE NRFIT NEEDLES; HOWEVER UPON CLOSER INSPECTION THEY CONFIRMED THE NRFIT SYRINGE CONTAINED A DEFECT.
NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1885164 | BD® 10ML SYRINGE NRFIT¿ LOK (STERILE) | PISTON SYRINGE WITH NEURAXIAL CONNECTOR | QEH | BECTON DICKINSON MEDICAL SYSTEMS | 400174 | 1041220 | 00382904001742 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |