BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGES (W/O NEEDLE)

    MDR report key: 13151444 · Received January 4, 2022

    Report

    Report Number
    13151444
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Date of Event
    November 10, 2021
    Report Date
    November 11, 2021
    Manufacturer
    DYNAREX CORPORATION
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    10 CC LUER LOCK SYRINGE USED TO ADMINISTER MEDICATION BY ANESTHESIA. LARGE AMOUNTS OF FLUID FROM THE SYRINGE VISUALIZED DRIPPING ONTO THE FLOOR, DESPITE FULL ENGAGEMENT OF THE INJECTION PORT. AFTER RE-ENGAGING THE INJECTION PORT TO DRAW UP FLUID FROM THE IV BAG, MORE THAN 1/2 THE SYRINGE PULLED IN AIR ALONG WITH THE FLUID. WE WERE ABLE TO REPRODUCE RESULTS WITH A NEW 100 CC LUER LOCK SYRINGE (SAME LOT # AS THAT WAS ALL THAT WAS AVAILABLE). SAFETY ISSUE FOR MEDICATION ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226623 SYRINGES (W/O NEEDLE) SYRINGE, PISTON FMF DYNAREX CORPORATION 6990 47783

    Patients

    Seq Age Sex Outcome Treatment
    1 26645 DA Male