BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 3132264 · Received May 29, 2013

    Report

    Report Number
    1119193-2013-00010
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 28, 2013
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, NO PRODUCT WAS AVAILABLE FOR TESTING AND NO LOT NUMBER WAS PROVIDED. WITHOUT THE BENEFIT OF EVALUATION AND TESTING, HOLLISTER IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED OCCURRENCE. COMPLAINT DATA WAS REVIEWED AND NO OBVIOUS TRENDS WERE OBSERVED. NO REPORTED PATIENT INJURY WAS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED: DURING ROUTINE PATIENT CARE, THE RESPIRATORY THERAPIST NOTED THAT THE LATCH HOLDING THE ANCHORFAST ENDOTRACHEAL TUBE HOLDER STRAP APPEARED TO BE BROKEN. THE ET TUBE STRAP WAS STILL AROUND THE ET TUBE AND THE PATIENT REMAINED INTUBATED. THE DEVICE HAD BEEN ON THE PATIENT APPROXIMATELY 10 MINUTES WHEN THE BROKEN LATCH WAS OBSERVED. SHE REMOVED THE BROKEN DEVICE AND REPLACED IT WITH A NEW ANCHORFAST ENDOTRACHEAL TUBE HOLDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237448 ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER ANCHORFAST ETAD CBH HOLLISTER INCORPORATED 9799

    Patients

    Seq Age Sex Outcome Treatment
    1