BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE, FIXATION, TRACHEAL TUBE

    MDR report key: 9134534 · Received September 30, 2019

    Report

    Report Number
    9134534
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    September 4, 2019
    Report Date
    September 5, 2019
    Manufacturer
    PEPPER MEDICAL, INC.
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UPON REPOSITIONING PATIENT, BLUE STRAP OF TRACH TIES DISCOVERED TO BE TORN. THIS IS THE VELCRO STRAP SECURED TO BACK OF TRACH HOLDER, ALONG THE LEFT SIDE OF THE NECK, BELOW THE LEFT EAR ( NOT THE WHITE VELCRO STRAPS ATTACHED TO THE PLANGES OF THE CUFFED BIVONA TRACH). THIS PRODUCT WAS PEPPER MEDICAL PEDIATRIC TRACHEOSTOMY TUBE HOLDER # 502. THESE TRACH TIES WERE NEW FROM 22:30 WHEN THIS RN AND THE RESPIRATORY THERAPIST PERFORMED TRACH AND TRACH TIE CARE. PATIENT REPOSITIONED SIDE TO SIDE X2 AFTER THE INITIAL TRACH TIE CHANGE WITHOUT INCIDENCE, UNTIL DETECTION AT 03:00 THE NEXT MORNING THAT THE SECURING BLUE VELCRO TAB WAS TORN, NO LONGER ADEQUATELY SECURING THE TRACHEOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928521 DEVICE, FIXATION, TRACHEAL TUBE CBH PEPPER MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 6205 DA