BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALRUS IV COMPONENT

    MDR report key: 1022455 · Received March 31, 2008

    Report

    Report Number
    3005789918-2008-00001
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 31, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FPA
    PMA / PMN Number
    K830755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN, THAT THE TUBING SET WAS BEING USED ON A MALE CHILD PT. THE IV SET BECAME DISCONNECTED AT ONE OF THE LUER LOCK CONNECTIONS NEAR THE PRESSURE ACTIVATED VALVE (PAV). THE PT BLED BACK THROUGH THE DISCONNECTED LINE. THERE WERE NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALRUS IV COMPONENT WALRUS PRODUCTS FPA ARROW INTERNATIONAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK