BEUDAMED
    FDA Adverse Event Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 2924975 · Received January 22, 2013

    Report

    Report Number
    1119193-2013-00001
    Date Received
    January 22, 2013
    Report Date
    January 17, 2013
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN HOW LONG THE DEVICES WERE IN PLACE PRIOR TO THE STATED TUBE SLIPPAGE. THE ADHESIVE ON THE ENDOTRACHEAL TUBE HOLDER IS NOT THE PRIMARY MODE OF TUBE SECUREMENT. THE IFU STATES TO "LOOP THE WRAP TIGHTLY AROUND THE TUBE AND PULL THE REMAINING PORTION THROUGH THE SECURITY CLAMP". THERE IS NO INFORMATION AS TO WHETHER THE WRAP WAS PULLED AND CLAMPED TIGHTLY TO SECURE THE TUBE. AN EVALUATION OF THE COMPLAINTS TREND ANALYSIS FOR THE LAST THREE MONTHS FOUND IT TO BE WITHIN STATISTICAL CONTROL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FACILITY HAS EXPERIENCED A NUMBER OF TUBES MIGRATING OUT OF THE ANCHORFAST ORAL ENDOTRACHEAL TUBE HOLDER. THE RESPIRATORY THERAPIST CLINICIAN STATED THAT THE ADHESIVE ON THE STRAP USED TO HELP HOLD THE TUBE IN PLACE IS BREAKING DOWN FROM PATIENT SECRETIONS RESULTING IN LOSS OF AIRWAY AND REQUIRING REINTUBATION. SHE ALSO STATED THAT THE FACILITY NO LONGER HAS A SET PERIOD OF TIME PRIOR TO CHANGING OUT THE DEVICE WHICH IS RESULTING IN EACH DEVICE BEING USED FOR A LONGER PERIOD OF TIME. THIS CHANGED FROM THEIR PREVIOUS 3-DAY PROTOCOL. SHE IS UNSURE IF THE SLIPPING IS ASSOCIATED WITH THE LONGER USE OF THE DEVICE BUT SHE WILL INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30909 ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER ANCHORFAST ETAD CBH HOLLISTER INCORPORATED 9799

    Patients

    Seq Age Sex Outcome Treatment
    1 Other