BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACERATION TRAY

    MDR report key: 23077475 · Received September 17, 2025

    Report

    Report Number
    MW5176207
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    September 13, 2025
    Report Date
    September 13, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OJV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE USING THE CARDINAL HEALTH LACERATION TRAY COMBAT APPLICATION TOURNIQUET (CAT) HT06-8400, THE FORCEPS HOLDER WOULD NOT HOLD A NEEDLE SECURELY. THE FORCEP HOLDERS WOULD OPEN UP WHEN ATTEMPTING TO SUTURE A LACERATION IN THE EMERGENCY DEPARTMENT. THE PHYSICIAN STATES ANOTHER DAY HE WAS UNABLE TO GET FORCEP HOLDERS TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2577536 LACERATION TRAY SINGLE USE INSTRUMENT TRAY KIT OJV CARDINAL HEALTH 200, LLC STK2UPRED 526054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown