BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW'S TRACHEOTOMY HOOK OVER LGTH 6-1/2IN

    MDR report key: 1901334 · Received November 17, 2010

    Report

    Report Number
    1923569-2010-00003
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    July 16, 2010
    Report Date
    November 17, 2010
    Manufacturer
    CAREFUSION
    Product Code
    KCH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS INITIATED INTO THE MATTER OF "BENT" TRACHEOTOMY HOOK DURING USE. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. WITHOUT DEVICE CAUSE FOR FAILURE COULD NOT BE DETERMINED OR THE ISSUE CONFIRMED. A HISTORICAL COMPLAINT REVIEW WAS CONDUCTED WITH NO TREND FOUND FOR THIS TYPE OF COMPLAINT ON THIS PRODUCT CODE. IF THE DEVICE IS RETURNED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    SEVERAL TRACHEOTOMY HOOKS BENT DURING A PROCEDURE. THE PHYSICIAN WAS USING A TRACHEOTOMY HOOK DURING AN EMERGENCY TRACHEOTOMY ON A (B)(6) MALE PATIENT WITH ANGIOEDEMA WHEN THE HOOK BENT. THE PHYSICIAN REQUESTED ANOTHER TRACHEOTOMY HOOK AND IT ALSO BENT. A TOTAL OF FOUR TRACHEOTOMY HOOKS BENT BEFORE THE PHYSICIAN SWITCHED TO ANOTHER PRODUCT TO FINISH THE CASE. NO SAMPLES FOR INVESTIGATION AS THE BENT HOOKS WERE ALL DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEW'S TRACHEOTOMY HOOK OVER LGTH 6-1/2IN TRACHEOTOMY HOOK KCH CAREFUSION BE395

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention