BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND GUIDED PIV KIT

    MDR report key: 11831374 · Received May 14, 2021

    Report

    Report Number
    MW5101365
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    May 11, 2021
    Report Date
    May 12, 2021
    Manufacturer
    MEDICAL ACTION INDUSTRIES INC
    Product Code
    OWL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EMPLOYEE NOTICED THAT THE MEDICAL ACTION PRODUCT "ULTRASOUND GUIDED PIV KIT" WAS HALF OPEN. I THEN WENT THROUGH THE SUPPLIES AND NOTED SEVERAL OF SAME LOT NUMBER WERE OPEN. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725686 ULTRASOUND GUIDED PIV KIT PERIPHERAL CATHETER INSERTION KIT OWL MEDICAL ACTION INDUSTRIES INC 270603

    Patients

    Seq Age Sex Outcome Treatment
    1