BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HY-TAPE

    MDR report key: 19613169 · Received June 26, 2024

    Report

    Report Number
    19613169
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    April 16, 2024
    Report Date
    June 17, 2024
    Manufacturer
    HY-TAPE INTERNATIONAL, INC.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REGISTERED NURSE (RN) RESPONDED TO DESATURATION ALARM OF 87% ON INTUBATED PATIENT DOING SKIN TO SKIN WITH MOTHER OF BABY (MOB). UPON THIS RN ASSESSMENT, RN NOTICED ENDOTRACHEAL TUBE (ETT) WAS AT 5.5 (ORDERED TUBE PLACEMENT IS 6.5) AND THAT THE INFANT HAD AN AIRLEAK. RN CALLED REGISTERED RESPIRATORY THERAPIST (RRT), NEONATE NURSE PRACTITIONER (NNP) AND RESOURCE RN TO BEDSIDE. INFANT PLACED BACK IN ISOLETTE. RN AND RRT USED NEOPUFF WITH PEDICAP TO ASSESS TUBE PLACEMENT. NEGATIVE COLOR CHANGE. ETT REMOVED. INFANT PLACED ON CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP). NNP AT BEDSIDE. ORDER FOR BCPAP PEEP 7. UPON ASSESSMENT OF REMOVED ETT, STAFF OBSERVED THE HY-TAPE HAD SLID FROM ORIGINAL TAPED POSITION RESULTING IN EXTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626221 HY-TAPE TAPE AND BANDAGE, ADHESIVE KGX HY-TAPE INTERNATIONAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown