BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL BNS

    MDR report key: 11426778 · Received March 7, 2021

    Report

    Report Number
    1911916-2021-00183
    Event Type
    Malfunction
    Date Received
    March 7, 2021
    Date of Event
    February 8, 2021
    Report Date
    February 26, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0196111, MEDICAL DEVICE EXPIRATION DATE: 2025-06-30, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0196113, MEDICAL DEVICE EXPIRATION DATE: 2025-06-30, DEVICE MANUFACTURE DATE: (B)(6) 2020. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50ML LL BNS PLUNGER WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A COMPLAINT FROM A CUSTOMER DUE TO "BROKEN" PLUNGERS ON 50ML SYRINGES. INITIAL INSPECTION SUGGESTED THAT THE DEFECT WAS THE RESULT OF INCOMPLETE MOULDING (THERE ARE NO SHARP EDGES INDICATING A BREAK) BUT THIS DOES NOT SEEM TO BE THE CASE AS THERE WERE ALSO PLUNGERS WHERE THE PIECE HAD NOT DETACHED. WHERE A PIECE OF THE PLUNGER WAS MISSING ENTIRELY THE CUSTOMER REPORTED NO CORRESPONDING BROKEN PIECES IN THE PACK. SIMILARLY WHERE THE PIECE WAS STARTING TO BREAK AWAY, IT COULD NOT BE EASILY DETACHED. WE DO NOT THINK IT LIKELY THAT THIS ISSUE OCCURRING AS A RESULT OF EITHER OUR OWN OR OUR CUSTOMER'S PROCESSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326932 SYRINGE 50ML LL BNS PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1