BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEO-FIT

    MDR report key: 488983 · Received October 8, 2003

    Report

    Report Number
    488983
    Event Type
    Malfunction
    Date Received
    October 8, 2003
    Date of Event
    December 1, 2002
    Report Date
    December 1, 2002
    Manufacturer
    COOPERSURGICAL (FORMERLY ACKRAD LABORATORIES, INC.)
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    "NEO-FIT" ENDOTRACHEAL TUBE HOLDER CONTAINS HARD PLASTIC PORTION INSIDE OF A FOAM BACKING. THE FOAM BACKING SEPARATED, ALLOWING THE HARD PLASTIC TO STICK OUT NEAR THE PT'S EYE AND NOSE. A SMALL BRUISED AREA WAS NOTED ON THE RIGHT ANTERIOR NARE OF THE PT AS A RESULT OF THE SEPARATION. NO TREATMENT WAS REQUIRED, AND THE INJURY DID NOT AFFECT THE PT'S OUTCOME. THE DEVICE WAS THE APPROPRIATE SIZE FOR THE PT'S ENDOTRACHEAL TUBE AND THE PT'S AGE AND WEIGHT. THE DEVICE WAS WORN FOR LESS THAN 72 HOURS. THE EXPECTED WEAR TIME OF THIS DEVICE IS UNKNOWN. THE INTENSIVE CARE UNIT IS NO LONGER USING THE DEVICE. THEY ARE TAPING ET TUBES WITH TAPE INSTEAD OF USING THE DEVICE. LITERATURE FROM THE MFR STATES, "SEPARATION OF THE PLASTIC BASE FOOT FROM THE ADHESIVE FOAM PAD MAY RESULT IN POTENTIAL ET TUBE EXTUBATION. IF SIGNS OF DELAMINATION ARE OBSERVED, REPLACE WITH A NEW NEO-FIT." THE MFR ACKNOWLEDGES THAT SEPARATION IS POSSIBLE WHEN USING THIS DEVICE. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEO-FIT NEONATAL ENDOTRACHEAL TUBE HOLDER CBH COOPERSURGICAL (FORMERLY ACKRAD LABORATORIES, INC.) REF. 42-2540 1475

    Patients

    Seq Age Sex Outcome Treatment
    1 23 DA Other THE PATIENT WAS INTUBATED AND ON A VENTILATOR.