BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK MEDICAL

    MDR report key: 4244105 · Received November 11, 2014

    Report

    Report Number
    4244105
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 11, 2014
    Manufacturer
    COOK INC
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE WAS USED FOR PARACENTESIS AND IT WAS DETERMINED THAT THE NEEDLE WAS NOT ALLOWING THE CATHETER EASY ENTRY. THIS OCCURRED ON 5 SEPARATE PROCEDURES FROM A SPECIFIC LOT NUMBER (#5251097). THE OTHER DEVICE FAILURES CAME FROM DIFFERENT LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727412 COOK MEDICAL YUEH CENTESIS DISPOSABLE CATHETER NEEDLE GAA COOK INC DTVN-5.0-19-7.0-YUEH 5251097

    Patients

    Seq Age Sex Outcome Treatment
    1