BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDCOMP DL VASCU-PICC

    MDR report key: 15690359 · Received October 28, 2022

    Report

    Report Number
    15690359
    Event Type
    Malfunction
    Date Received
    October 28, 2022
    Date of Event
    October 4, 2022
    Report Date
    October 17, 2022
    Manufacturer
    MEDICAL COMPONENTS INC
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    2.6F DL PICC PLACED URGENTLY EARLIER IN DAY. WHITE LUMEN OF LINE USED FOR INTERMITTENT MEDICATIONS PER STAFF NURSE, FOUND LEAKING. ATTEMPTED PICC RE-WIRE/EXCHANGE UNSUCCESSFULLY BY 2 VAS NURSES RESULTING IN LOSS OF LINE AS NOTHING WOULD THREAD. NO OTHER SITES NOTED FOR PICC REPLACEMENT AT THE TIME, DISCUSSED WITH 7S TEAM. UPON INSPECTION OF LINE NOTED TO HAVE RUPTURED 1-1.5CM FROM HUB OF WHITE LUMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2871846 MEDCOMP DL VASCU-PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS MEDICAL COMPONENTS INC MQGL810

    Patients

    Seq Age Sex Outcome Treatment
    1 30 DA Female