BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAMIC STOPCOCK 400 PSI THREEWAY STOPCOCK W / FIXED MALE LUER LOCK

    MDR report key: 9596307 · Received January 15, 2020

    Report

    Report Number
    MW5092303
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    January 10, 2020
    Report Date
    January 14, 2020
    Manufacturer
    NAVILYST MEDICAL / ANGIODYNAMICS, INC.
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN DID A POWER INJECTION WITH 400PSI STOPCOCK AND IT IMMEDIATELY MALFUNCTIONED WITH NEXT HAND INJECTION. STOPCOCK BEGAN LEAKING AND WAS REMOVED AND A NEW THREE WAY STOPCOCK WITH 1050 PSI WAS USED WITHOUT ISSUE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57031 NAMIC STOPCOCK 400 PSI THREEWAY STOPCOCK W / FIXED MALE LUER LOCK ADAPTOR, STOPCOCK, MANIFIED FITTING CARDIO PULMONARY BYPASS DTL NAVILYST MEDICAL / ANGIODYNAMICS, INC. H965700350030 5533373

    Patients

    Seq Age Sex Outcome Treatment
    1