BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED®

    MDR report key: 18484510 · Received January 10, 2024

    Report

    Report Number
    18484510
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    July 31, 2023
    Report Date
    August 16, 2023
    Manufacturer
    WALKMED, LLC
    Product Code
    BTC
    UDI-DI
    00859695006060
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    FROM DETAILS IN THIS EVENT REPORT, THE SLIT IN TUBING WAS LIKELY A PUNCTURE, NOT DEFECTED PRODUCT. UNSURE OF EXACT PRODUCT USED, BUT THIS IS THE PRODUCT ON HAND INFORMATION: BAG = REF: 21-7059-24 LOT 4372852. SET = REF: 204822 LOT 20322508.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143110 WALKMED® BAG, RESERVOIR BTC WALKMED, LLC 204822 00859695006060

    Patients

    Seq Age Sex Outcome Treatment
    1 21900 DA Male