BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRITICAL DISPOSABLES

    MDR report key: 328524 · Received April 19, 2001

    Report

    Report Number
    1033554-2001-00011
    Event Type
    Malfunction
    Date Received
    April 19, 2001
    Manufacturer
    DEROYAL
    Product Code
    BYX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED PRESSURE LINE SPLIT UNDER PRESSURE OF 800-900 PSI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17958 CRITICAL DISPOSABLES 48" HIGH PRESSURE LINE BYX DEROYAL NA 027781

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other