BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENSOPLAST TAPE 1IN X 5YDS STRETCHED

    MDR report key: 15904437 · Received December 2, 2022

    Report

    Report Number
    15904437
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 11, 2022
    Report Date
    November 21, 2022
    Manufacturer
    BSN MEDICAL
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ALL NEONATAL INTENSIVE CARE UNIT (ICU) ENDOTRACHEAL TUBE (ET) TUBE HOLDERS WERE RECALLED AND AS SUCH, WE HAD TO REMOVE THEM FROM STOCK IMMEDIATELY. ET TUBE HOLDERS WERE CHANGED TO ELASTOPLAST TAPE FOR SECURITY. INFANT NOTED TO BE DESATURATING ON MONITOR. UPON EXAMINATION SHE WAS VERY DUSKY WITH RAPIDLY DECREASING HEART RATE AND SPO2 READING. DETERMINED INFANT SELF-EXTUBATED AND OSCILLATOR BECAME DISCONNECTED WHICH ENDED ALL RESPIRATORY SUPPORT. HEART RATE FELL TO LOW OF 40 BPM AND SPO2 23%. NEW ETT SECUREMENT TAPE WAS NO LONGER STICKY AND CAME OFF INFANT'S FACE LEADING TO ETT DISLODGEMENT. IMMEDIATELY ENLISTED AIDE OF 2 ADDITIONAL RN'S, 1 RT, AND 2 FELLOWS ON DUTY. PPV BEGAN AND CONTINUED THROUGH SUCCESSFUL RE-INTUBATION. IMMEDIATE CHEST/ABDOMEN X-RAY OBTAINED TO CONFIRM PLACEMENT. INFANT WITHOUT ADEQUATE OXYGENATION FOR THIS 16- MINUTE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385548 TENSOPLAST TAPE 1IN X 5YDS STRETCHED TAPE AND BANDAGE, ADHESIVE KGX BSN MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 DA Female Other