BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-TIP .25

    MDR report key: 20834460 · Received December 3, 2024

    Report

    Report Number
    2027063-2024-11211
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    October 5, 2024
    Report Date
    October 30, 2024
    Manufacturer
    NATIONAL MEDICAL PRODUCTS, INC.
    Product Code
    KZE
    PMA / PMN Number
    K973254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ONE OF THE NURSES WAS USING THIS J TIP APPLICATOR AND WHEN HE PRESSED THE LITTLE LEVER TO RELEASE THE GAS TO PUT SOME MEDICATION INTO THE PATIENT UNDER THE SKIN, IT EXPLODED. IT SOUNDED LOUDER THAN NORMAL, LIKE A GUNSHOT. THE WHOLE BOTTOM PART CRACKED, SPLIT OPEN. IT LOOKS LIKE THE RUBBER PORTION OF IT IS STICKING OUT OF THE BOTTOM. THERE WAS A LOT OF PRESSURE TO CRACK THIS IN HALF AND HAVE THAT LITTLE RUBBER ALMOST EJECTED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2218653 J-TIP .25 INJECTOR, FLUID, NON-ELECTRICALLY POWERED KZE NATIONAL MEDICAL PRODUCTS, INC. 8164-2001-25 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown