BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 2971710 · Received January 30, 2013

    Report

    Report Number
    9611710-2013-00052
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    July 6, 2010
    Report Date
    April 6, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE HAS BEEN REVIEWED, AND DEEMED A MALFUNCTION. BASED ON CURRENT INFO, RECURRENCE OF THIS MALFUNCTION WOULD LIKELY LEAD TO A SERIOUS ADVERSE EVENT BECAUSE ET TUBES ARE OFTEN USED UNDER EMERGENCY CONDITIONS WHEN HEALTH CARE PERSONNEL CANNOT ALWAYS TAKE TIME TO EXAMINE THE INTEGRITY OF THE PRODUCT BEFORE USE. FURTHER, EVENT WHEN THE TUBES ARE NOT USED FOR EMERGENCY PURPOSES, THE PROCEDURE CAN BE SOMEWHAT DIFFICULT AND THE HEALTH CARE PROFESSIONAL IS INTENT ON VIEWING THE AIRWAY WHILE USING THE TUBE. THEY WOULD LIKELY NOT SEE A HAIR ON THE PRODUCT WHICH COULD BE INSERTED IN THE AIRWAY ALONG WITH THE TUBE. THIS FOREIGN BODY INVASION OF THE AIRWAYS COULD LEAD TO INFECTION OR OTHER MORE SERIOUS COMPLICATIONS. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW OF COMPLAINTS FROM OUR FACILITY IN (B)(4). COMPLAINT REC'D AS FOLLOWS: CUSTOMER'S COMPLAINT NO: (B)(4), QTY - 19. FOREIGN SUBSTANCE IN PKG: 13 PIECES. HAIR IN PKG: 3 PIECES. DEFORMED: 3 PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41822 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TUBE, TRACHEAL BTR UNOMEDICAL SDN BHD 61110075 604336R001

    Patients

    Seq Age Sex Outcome Treatment
    1