BD® PLASTIC NRFIT¿ SYRINGE
Report
- Report Number
- 1213809-2022-00552
- Event Type
- Malfunction
- Date Received
- September 9, 2022
- Date of Event
- August 16, 2022
- Report Date
- November 13, 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
- 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.
INVESTIGATION SUMMARY: EIGHTY-THREE SAMPLES AND FIVE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT NINETEEN 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 SAMPLES ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED.
(B)(4) FOLLOW UP REPORT #2 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 THAT THE BD® PLASTIC NRFIT¿ SYRINGE WAS WITH OR WITHOUT LUERLOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: WE HAVE FOUND THAT FOR ITEM NUMBER 400174 WITH LOT NUMBER 1041220, THERE ARE PRODUCTS WITH AND WITHOUT LUERLOCK.
IT WAS REPORTED THAT THE BD® PLASTIC NRFIT¿ SYRINGE WAS WITH OR WITHOUT LUERLOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: WE HAVE FOUND THAT FOR ITEM NUMBER 400174 WITH LOT NUMBER 1041220 THERE ARE PRODUCTS WITH AND WITHOUT LUERLOCK.
NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2215848 | BD® PLASTIC NRFIT¿ SYRINGE | PISTON SYRINGE | QEH | BECTON DICKINSON MEDICAL SYSTEMS | 400174 | 1041220 | 00382904001742 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |