BEUDAMED
    FDA Adverse Event Other Summary report: N

    PICC LINE KIT

    MDR report key: 19359282 · Received May 20, 2024

    Report

    Report Number
    MW5155153
    Event Type
    Other
    Date Received
    May 20, 2024
    Report Date
    May 16, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
    Product Code
    LJS
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SECOND SIMILAR EVENT - PICC LINE KIT, REF CDC-45041-VPS2, LOT 33F23H0294. VPS SYSTEM WOULD NOT WORK UPON STARTING VPS MONITOR AFTER VPS GUIDEWIRE WAS PLUGGED IN. ANOTHER KIT WAS OPENED TO RETRIEVE NEW VPS WIRE, AND THE NEW WIRE WORKED PERFECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505840 PICC LINE KIT CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) 33F23H0294 VPS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown