BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE
Report
- Report Number
- 3003152976-2021-00886
- Event Type
- Malfunction
- Date Received
- January 7, 2022
- Date of Event
- December 10, 2021
- Report Date
- February 14, 2022
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- 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.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-01-06 . H6: INVESTIGATION SUMMARY SIXTEEN SAMPLES AND PHOTOS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, IT CAN BE OBSERVED POLYPROPYLENE FIBERS IN THE TIP OF ALL OF THEM. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2011103, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. POSSIBLE ROOT CAUSE, THE POLYPROPYLENE FIBER HAS BEEN GENERATED IN THE JOINT LINE OF THE ROOF AND CYLINDER. THIS DEFECT COULD HAVE BEEN GENERATED DURING MOLDING PROCESS DUE TO A FAILURE IN THE MOLD AT THIS JOINT LINE OR DURING PIECES TRANSPORT PROCESS. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES.
IT WAS REPORTED THAT SMALL PLASTIC TAGS/SHEDS WERE ATTACHED TO THE TIP OF BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE. THIS EVENT OCCURRED 16 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RECENT DELIVERY OF 305959 BD 10 ML SYRINGES (LOT # 2011103) HAS FAILED OUR QUALITY INSPECTION. WE FOUND 16 OUT OF 200 SYRINGES (8.0 %) WITH SMALL PLASTIC ¿TAGS¿ OR ¿SHREDS¿ ATTACHED TO THE TIP OF THE SYRINGE. WHILST THIS IS A MINOR DEFECT IN TERMS OF THE NATURE OF THE DEFECT ITSELF, THE LOCATION OF THESE PLASTIC PARTICLES MEANS THAT THERE¿S A GOOD POSSIBILITY OF THEM DETACHING AND GOING INTO OUR FILLED SYRINGES IN WHICH CASE THIS WOULD BE A CRITICAL DEFECT AND IF THE PRODUCT WERE ON THE MARKET A LIKELY RECALL. THE LAST PHOTO SHOWS A PLASTIC SHRED ON THE OUTSIDE OF THE LUER LOCK REGION, WHICH WOULD BE CONSIDERED A MINOR / LOW RISK BUT THE SYRINGE ALSO HAS A ROUGH AREA ON THE TIP WHICH MAY BE ABLE TO BREAK OFF. MOREOVER DEFECT LEVEL OF 8.0 % WOULD NOT PASS AN AQL FOR ANY TYPE OF DEFECT.
IT WAS REPORTED THAT SMALL PLASTIC TAGS/SHEDS WERE ATTACHED TO THE TIP OF BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE. THIS EVENT OCCURRED 16 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RECENT DELIVERY OF 305959 BD 10 ML SYRINGES (LOT # 2011103) HAS FAILED OUR QUALITY INSPECTION. WE FOUND 16 OUT OF 200 SYRINGES (8.0 %) WITH SMALL PLASTIC ¿TAGS¿ OR ¿SHREDS¿ ATTACHED TO THE TIP OF THE SYRINGE. WHILST THIS IS A MINOR DEFECT IN TERMS OF THE NATURE OF THE DEFECT ITSELF, THE LOCATION OF THESE PLASTIC PARTICLES MEANS THAT THERE¿S A GOOD POSSIBILITY OF THEM DETACHING AND GOING INTO OUR FILLED SYRINGES IN WHICH CASE THIS WOULD BE A CRITICAL DEFECT AND IF THE PRODUCT WERE ON THE MARKET A LIKELY RECALL. THE LAST PHOTO SHOWS A PLASTIC SHRED ON THE OUTSIDE OF THE LUER LOCK REGION, WHICH WOULD BE CONSIDERED A MINOR / LOW RISK BUT THE SYRINGE ALSO HAS A ROUGH AREA ON THE TIP WHICH MAY BE ABLE TO BREAK OFF. MOREOVER DEFECT LEVEL OF 8.0 % WOULD NOT PASS AN AQL FOR ANY TYPE OF DEFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 794500 | BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON, S.A. | 2011103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |