PLASTIPAK LUER-LOK
Report
- Report Number
- 2243072-2026-00218
- Event Type
- Malfunction
- Date Received
- March 18, 2026
- Date of Event
- March 11, 2026
- Report Date
- May 15, 2026
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMF
- UDI-DI
- 00382903008650
- PMA / PMN Number
- SEE H.11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
(B)(4). FOLLOW UP REPORT FOR CORRECTION. MFR REPORT # 3003152976-2026-00147 WAS FILED AS THE SITE LEGAL NAME WAS INCORRECTLY REPORTED AS FRANKLIN LAKES IN THE INITIAL MDR SUBMISSION, 2243072-2026-00218. MFR REPORT # 3003152976-2026-00147 WAS SUBMITTED TO UPDATE THE SITE LEGAL NAME TO SAN AGUSTIN, AND TO HAVE THE PROPER MFR NUMBER.
THE FOLLOWING APPLICABLE 510K NUMBERS WERE LISTED: K182589;K980987. D.3. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. G.1. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
(B)(4). FOLLOW UP REPORT FOR CORRECTION AND DEVICE EVALUATION. THIS REPORT IS SUPPLEMENTAL TO PREVIOUSLY SUBMITTED 3003152976-2026-00147, THE FAILURE WAS DETERMINED TO NOT BE A REPORTABLE EVENT AFTER THE MDR WAS SUBMITTED. ONE PHOTO AND TWO PHYSICAL SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON EVALUATION, A GREY PARTICLE WAS OBSERVED WITHIN ONE SYRINGE, CONSISTENT WITH THE PHOTO PROVIDED. ADDITIONALLY, EMBEDDED PARTICLES WERE IDENTIFIED WITHIN THE BARREL OF THE SECOND SYRINGE. CHARACTERIZATION TESTING WAS PERFORMED AND IDENTIFIED THE GREY PARTICLE IS CONSISTENT WITH MATERIAL FROM A VIAL STOPPER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE SUSPECTED LOTS, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THESE OBSERVATIONS. PRODUCTS FROM THIS MANUFACTURING LINE ARE ROUTINELY SAMPLED AND SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT VARIOUS STAGES OF PRODUCTION, IN ACCORDANCE WITH ESTABLISHED PROCEDURES. NO ISSUES RELATED TO THE REPORTED CONCERN WERE IDENTIFIED DURING THESE INSPECTIONS. BASED ON THE SAMPLE EVALUATION AND DEVICE HISTORY REVIEW, IT WAS DETERMINED THAT THE GREY PARTICLE ORIGINATED FROM THE VIAL STOPPER DURING WITHDRAWAL WHILE THE EMBEDDED MATERIAL GENERATED DURING THE MOLDING PROCESS. MACHINES UNDERGO ROUTINE CLEANING AND MAINTENANCE AND INJECTION MACHINES ARE RAN PRIOR TO USE TO REMOVE ANY EXCESS MATERIALS, REJECTING THE FIRST FEW PIECES. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.
NO ADDITIONAL INFORMATION PROVIDED.
IT WAS REPORTED THAT THE BD SYRINGE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT#251101. IT WAS REPORTED THAT MEDICATION PREPARATION BY A REGISTERED NURSE: DIFFICULTY DRAWING UP A SYRINGE OF HOC FROM A BOTTLE OF SALINE SOLUTION. NEEDLE CHANGED, SAME PROBLEM. ULTIMATELY, SALINE DRAWN INTO A 50 ML SYRINGE: DISCOVERY OF A PLASTIC ¿CARROT¿ IN THE SYRINGE. SYRINGE RETAINED AND ONE NEEDLE FROM THE SAME BATCH COLLECTED FOR MEDICAL DEVICE SURVEILLANCE. PROVEN CONSEQUENCES: PLASTIC IN A SYRINGE (SEE PHOTO): MAJOR RISK TO THE PATIENT WASTED TIME.
AS PER THE INVESTIGATION FINDINGS, CHARACTERIZATION TESTING WAS PERFORMED AND THE GREY PARTICLE NOTED WITHIN THE SYRINGE WAS IDENTIFIED TO BE CONSISTENT WITH MATERIAL FROM A VIAL STOPPER AND NOT FROM THE SYRINGE ITSELF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347261 | PLASTIPAK LUER-LOK | PISTON SYRINGE | FMF | BECTON DICKINSON | UNKNOWN | 00382903008650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |