BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL 120/PKG

    MDR report key: 9775912 · Received March 2, 2020

    Report

    Report Number
    3003152976-2020-00094
    Event Type
    Malfunction
    Date Received
    March 2, 2020
    Date of Event
    February 11, 2020
    Report Date
    March 25, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SAMPLE AND THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED AND THE STOPPER WAS VERIFIED TO BE INCORRECTLY ASSEMBLED, DISTORTED AGAINST THE BARREL WALL. THE SAMPLE WAS DISASSEMBLED, THERE WAS NO DAMAGE OR DEFECTS OBSERVED IN THE PLUNGER THAT COULD HAVE CONTRIBUTED TO THIS DEFECT. A DEVICE HISTORY WAS PERFORMED FOR LOT 1903247, FINDING ONE ANNOTATION RELATED TO THE ALLEGED DEFECT. A FAILURE WAS DETECTED THAT RESULTED IN THE IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY. ONCE THE FAILURE WAS IDENTIFIED, IT WAS CORRECTED BY THE MECHANICAL TEAM. A CAMERA SYSTEM IS USED TO DETECT FOR ANY MISSING AND MISALIGNED STOPPERS, AUTOMATICALLY REJECTING ANY THAT ARE DETECTED. IT WAS DETERMINED THIS INCIDENT IS LIKELY RELATED TO THE FAILURE IDENTIFIED DURING ASSEMBLY WHICH CAUSE THE STOPPER TO DETACH DURING CUSTOMER USE. COMPLAINTS FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 20ML LL 120/PKG EXPERIENCED STOPPER DAMAGE/DEFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE UNIT HAD A DEGRADED/DEFORMED PLUNGER MAKING THE SYRINGE UNUSABLE AND NON-FUNCTIONAL.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 20 ML LL 120/PKG EXPERIENCED STOPPER DAMAGE/DEFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE UNIT HAD A DEGRADED/DEFORMED PLUNGER MAKING THE SYRINGE UNUSABLE AND NON-FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241171 SYRINGE 20ML LL 120/PKG SYRINGE FMF BECTON DICKINSON, S.A. 1903247

    Patients

    Seq Age Sex Outcome Treatment
    1 Other