BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASTIPAK LUER-LOK

    MDR report key: 24225275 · Received January 30, 2026

    Report

    Report Number
    3003152976-2026-00027
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    September 18, 2025
    Report Date
    March 4, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    K182589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: BOTH PHOTOS AND NINE PHYSICAL SAMPLES HAVE BEEN PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, SMALL PARTICLES ARE OBSERVED WITHIN SEVERAL OF THE RETURNED SYRINGES AND SOME OF THE PACKAGING AS WELL. FURTHER EVALUATION IDENTIFIED THE PARTICLES TO BE POLYPROPYLENE PARTICLES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2501079, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEANROOM ENVIRONMENT MAINTAINED UNDER POSITIVE PRESSURE TO MINIMIZE THE RISK OF FOREIGN MATTER. THE ASSEMBLY STATION UTILIZES A DE-IONIZER TO REMOVE ANY POLYPROPYLENE PARTICLES INSIDE THE BARREL, AND EQUIPMENT IS PROTECTED TO PREVENT PARTICLE GENERATION DURING COMPONENT MOVEMENT. FINAL PRODUCTS ARE SAMPLED AND SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT THE MANUFACTURING SUB-PROCESSES IN ACCORDANCE WITH ESTABLISHED PROCEDURES, AND NO ISSUES RELATED TO THIS INCIDENT WERE FOUND. ALTHOUGH NO DIRECT MANUFACTURING ISSUE WAS IDENTIFIED, THE PARTICLES LIKELY ORIGINATED DURING PRODUCT MOVEMENT WITHIN THE ASSEMBLY EQUIPMENT. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED TO INCREASE AWARENESS AND PREVENT RECURRENCE. COMPLAINTS RELATED TO THIS DEVICE AND CONDITION WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INITIAL MDR. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. RELATED TO MFR# 3003152976-2025-00724 WHICH REPRESENTS THE 08/21/2025 EVENT DATE MENTIONED IN THE EVENT DETAILS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    EVENT DETAILS: WE WOULD LIKE TO RAISE A CUSTOMER COMPLAINT FOR 50ML LUER-LOK¿ SYRINGE, (CAT. NO: 613-3925, LOT NO: 2501079). 9 UNITS WERE FOUND DEFECTIVE AS BELOW: UNIT 1: FREE FLOWING WHITE PLASTIC FIBER ON THE PLUNGER AND FREE FLOWING BLACK PARTICLE ON THE PLUNGER UNIT 2: PARTICLE INSIDE LUMEN. CANNOT TELL IF EMBEDDED/FREE FLOWING UNIT 3: FREE FLOWING PARTICLE IN FLUID PATH (ON PLUNGER) UNIT 4: X2 FREE FLOWING PARTICLES, BLACK DOTS INSIDE THE TUBE UNIT 5: X1 PARTICLE INSIDE TUBING (INSPECTION FORM DID NOT STATE WHETHER THIS WAS FREE FLOWING OR EMBEDDED) UNIT 6: X1 PARTICLE INSIDE TUBING (INSPECTION FORM DID NOT STATE WHETHER THIS WAS FREE FLOWING OR EMBEDDED) UNIT 7: BROWN PARTICLE INSIDE FLUID PATH, CANNOT DETERMINE IF FREE MOVING/EMBEDDED UNIT 8: X2 BROWN PARTICLES; CANNOT DETERMINE IF IN/OUT OF THE FLUID PATH UNIT 9: POTENTIAL FREE MOVING PARTICLE (FRAYING) ON PLUNGER. PER RESPONSE RECEIVED ON: 1/16/2026: I HAVE RECEIVED THE FOLLOWING RESPONSES FROM THE CUSTOMER: COULD YOU PLEASE CONFIRM WERE ALL 9 UNITS FOUND ON THE SAME DATE? 1 DEFECTIVE UNIT WAS IDENTIFIED ON (B)(6) 2025 DURING THE VISUAL INSPECTION ¿ SYRINGE CONTAINED FREE FLOWING WHITE PLASTIC FIBER ON THE PLUNGER AND FREE FLOWING BLACK PARTICLE ON THE PLUNGER. AS PER OUR MATERIAL SPECIFICATION, IF FREE FLOWING VISIBLE PARTICLE INSIDE THE SYRINGE FLUID PATH IS OBSERVED, LOT SHOULD BE QUARANTINED AND 100% INSPECTION MUST BE PERFORMED. 100% INSPECTION WAS PERFORMED ON 18SEP2025 AND THE REMAINING DEFECTS WERE IDENTIFIED. COULD YOU PLEASE CONFIRM WERE ANY OF THESE USED ON PATIENTS? NO, AS STATED PREVIOUSLY, THE DEFECTS WERE IDENTIFIED UPON THE VISUAL INSPECTION CONDUCTED AS PART OF THE MATERIAL RELEASE; WE WOULDN¿T USE THE MATERIAL WITH VISIBLE PARTICLES FOR MANUFACTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600148 PLASTIPAK LUER-LOK SYRINGE, PISTON FMF BECTON DICKINSON, S.A. 2501079 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1