BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML LL BNS

    MDR report key: 18710427 · Received February 15, 2024

    Report

    Report Number
    1213809-2024-00085
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 26, 2024
    Report Date
    May 16, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903096485
    PMA / PMN Number
    K941562
    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.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    TWO PHOTOS OF A 1ML LUER-LOK SYRINGE WERE RECEIVED AND EVALUATED. BOTH IMAGES SHOW A LOOSE SYRINGE FROM TWO DIFFERENT ANGLES, WITH THE STOPPER JAMMED BETWEEN THE BARREL AND THE PLUNGER ROD. A SAMPLE OF A 1 ML LUER-LOK SYRINGE WAS RECEIVED AND EVALUATED. THE SYRINGE WAS RECEIVED DISASSEMBLED. THE BARREL WAS LOOSE, AND THE PLUNGER ROD HAD A DEFORMED STOPPER CONSISTENT WITH A DISTORTED CONDITION. THE POTENTIAL ROOT CAUSE OF THE DISTORTED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BATCH NUMBER 1200757 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML LL BNS PLUNGER ROD WAS BROKEN/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM DUTCH TO ENGLISH: PLUNGER OF SYRINGE IS DAMAGED PLUNGER DAMAGED.

    Description of Event or Problem · 0

    PLUNGER OF SYRINGE IS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543204 BD SYRINGE 1ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1200757 50382903096485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown