BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 1962830 · Received January 13, 2011

    Report

    Report Number
    1119193-2011-00001
    Event Type
    Injury
    Date Received
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    HOLLISTER, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE REPOSITIONING THE PT FOR A LUMBAR PUNCTURE PROCEDURE, THE RT NOTICED THAT THE ENDOTRACHEAL TUBE HOLDER (ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER) HAD BROKEN AND THE PT HAD BECOME EXTUBATED. THE PT REQUIRED RE-INTUBATION. IT WAS REPORTED THAT THE PT REMAINED ON PROLONGED VENTILATION, HOSPITALIZATION AND WAS MOVED TO A HIGHER LEVEL OF CARE. THE ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER HAD BEEN IN PLACE FOR ABOUT 36 HRS PRIOR TO THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER ANCHORFAST ETAD CBH HOLLISTER, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other| R