BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALRUS

    MDR report key: 15137926 · Received August 1, 2022

    Report

    Report Number
    15137926
    Event Type
    Malfunction
    Date Received
    August 1, 2022
    Date of Event
    July 22, 2022
    Report Date
    July 25, 2022
    Manufacturer
    CODAN US CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IV TUBING USED IN PACU SEPARATED AT PLASTIC "WELD" NEAR STOPCOCKS. IT WAS NOT THE SCREW ON/LUER LOCK CONNECTION, IT WAS THE FUSED END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320440 WALRUS SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORPORATION B 2025-W 79095

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA Unknown