BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUHRMAN PLEURAL/ PNEUMOPERICARDIAL DRAINAGE SET AND TRAY

    MDR report key: 1053021 · Received May 19, 2008

    Report

    Report Number
    1053021
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 19, 2008
    Manufacturer
    COOK CRITICAL CARE
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    DURING REPOSITIONING IT WAS IDENTIFIED THAT CHEST TUBE WAS CURLED BY PATIENT'S SIDE. CHEST TUBE WAS GENTLY STRAIGHTENED. STAFF IDENTIFIED THAT CHEST TUBE CAME APART AT ADAPTER. CHEST TUBE WAS REMOVED. NO PATIENT IMPACT IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUHRMAN PLEURAL/ PNEUMOPERICARDIAL DRAINAGE SET AND TRAY CATHETER, DRAINAGE KDQ COOK CRITICAL CARE * LOT 1445685

    Patients

    Seq Age Sex Outcome Treatment
    1 16 DA