BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 3051430 · Received April 10, 2013

    Report

    Report Number
    1119193-2013-00005
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE SAMPLE WE ARE UNABLE TO EVALUATE THE REPORTED FOAM BUMPER SEPARATION FROM THE DEVICE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED: THERE WERE TWO INCIDENTS IN WHICH THE FOAM BUMPER OF THE ANCHORFAST ENDOTRACHEAL TUBE HOLDER SEPARATED FROM THE DEVICE WHILE IT WAS IN USE ON THE PATIENT. IN ONE CASE, THEY LOCATED THE FOAM BUMPER PIECE AND IN THE OTHER CASE THE FOAM BUMPER PIECE COULD NOT BE LOCATED. THE ANCHORFAST DEVICES WERE IN PLACE FOR 4-5 DAYS. ONE PATIENT HAD A LARGE AMOUNT OF ORAL SECRETIONS PRESENT WHILE ANCHORFAST WAS IN USE, THE OTHER DID NOT. ONE PATIENT HAD A MINOR SKIN ABRASION ABOUT THE LOCATION OF THE PLASTIC TRACK ON THE UPPER LIP WHICH DID NOT REQUIRE MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149924 ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER ANCHORFAST ETAD CBH HOLLISTER INCORPORATED 9799 2L142

    Patients

    Seq Age Sex Outcome Treatment
    1 Other