BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 3112010 · Received May 1, 2013

    Report

    Report Number
    1820334-2013-00184
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 11, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DRE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE DEVICE BROKE OFF IN THE PATIENT BETWEEN THE PLASTIC PART AND HUB. THE DEVICE WAS REMOVED FROM THE PATIENT USING TWEEZERS. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190901 MICROPUNCTURE TRANSITIONLESS ACCESS SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1