BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK 4 FRENCH 130 CM

    MDR report key: 2822853 · Received October 31, 2012

    Report

    Report Number
    MW5027484
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 31, 2012
    Manufacturer
    COOK MEDICAL
    Product Code
    GCB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INPATIENT UNDERGOING ULTRASOUND GUIDED DIAGNOSTIC AND THERAPEUTIC PARACENTESIS IN THE HOSPITAL'S RADIOLOGY INTERVENTIONAL DEPARTMENT. WHEN 50 ML SYRINGE WAS ATTACHED TO OBTAIN DIAGNOSTIC SPECIMENS, THE SHEATH DETACHED FROM THE HUB AND DISAPPEARED IN THE SUBCUTANEOUS FAT. DIAGNOSIS OR REASON FOR USE: ASCITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK 4 FRENCH 130 CM YUEH CATHETER CENTESIS DISPOSABEL GCB COOK MEDICAL G09646 3425137

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other