BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANCHORFAST ORAL ENDOTRACH TUBE FASTENER

    MDR report key: 16452895 · Received February 28, 2023

    Report

    Report Number
    1119193-2023-00003
    Event Type
    Death
    Date Received
    February 28, 2023
    Date of Event
    January 30, 2023
    Report Date
    February 28, 2023
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    UDI-DI
    00610075070220
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER PROVIDED. HOLLISTER COMPLETED A DHR REVIEW, AND THE RECORDS WERE FOUND TO BE COMPLETE AND ACCURATE. SAMPLE NOT RETURNED FOR TESTING SO SAMPLE EVALUATION NOT POSSIBLE. TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. HOLLISTER IS UNABLE TO DETERMINE THE ROOT CAUSE OF THIS REPORTED EVENT. HOLLISTER OFFERED PRODUCT TRAINING AND INSERVICING TO THE FACILITY. USER FACILITY SUBMITTED A VOLUNTARY MEDWATCH FOR THIS REPORT; MW5114898.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO NURSES WERE BATHING AND CHANGING THE LINENS OF A PATIENT WITH A HOLLISTER ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER IN PLACE. IT WAS REPORTED THAT THEY WERE ROLLING THE PATIENT FROM SIDE TO SIDE DURING THIS PROCESS WHEN THE ENDOTRACHEAL TUBE PULLED OUT. IT WAS ALSO REPORTED THAT THE PATIENT'S BLOOD PRESSURE CRASHED, THE PATIENT CODED, AND EXPIRED. IT WAS REPORTED THAT THERE WAS NOTHING WRONG WITH ET TUBE OR THE ANCHORFAST DEVICE. IN ADDITION, IT WAS REPORTED THAT THE ANCHORFAST DEVICE DID NOT BREAK. IT WAS REPORTED THAT THE VENTILATOR CIRCUIT HAD BEEN SUPPORTED BY A VENTILATOR ARM, THE PATIENT HAD A LOT OF ORAL SECRETIONS PRESENT AND THERE WAS NO RESPIRATORY THERAPIST IN THE ROOM MAINTAINING THE AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381955 ANCHORFAST ORAL ENDOTRACH TUBE FASTENER ORAL ENDOTRACHEAL TUBE FIXATION DEVICE CBH HOLLISTER INCORPORATED 2B092 00610075070220

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Death