BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBAR

    MDR report key: 2453691 · Received February 9, 2012

    Report

    Report Number
    2025917-2012-00005
    Event Type
    Malfunction
    Date Received
    February 9, 2012
    Date of Event
    December 12, 2011
    Report Date
    January 31, 2012
    Manufacturer
    NEOTECH PRODUCTS, INC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IN VIEW OF THE FACT THAT THE ORIGINAL FAILED DEVICE WAS NOT RETURNED, AND NO REMAINING DEVICE FROM THE SAME SHIPMENT, AND NOT LOT NUMBER FOR RETAINED SAMPLES, WE COULD NOT DO ANY DEVICE EVALUATION.

    Description of Event or Problem · 1

    TITLE: XXXXX. EVENT DESC: THERE HAVE BEEN 5 REPORTED INSTANCES OF GREY NEOBAR FAILURE AT THIS HOSPITAL IN (B)(6) 2011. ALL OF THESE ISSUES WERE WITH NEOBARS FROM LOT#21800. ON 4 SEPARATE OCCASIONS, THE DUODERM PAD ADHESION FAILED AND THE BAR BECAME DISENGAGED FROM THE ADHESIVE TAB. IN OTHER WORDS, THE ADHESIVE TAB ADHERED TO THE PATIENT'S FACE, BUT THE GREY PLASTIC ARM CAME LOOSE FROM THE ADHESIVE CONNECTION, CAUSING PROBLEMS WITH THE INTUBATION. FOUR OF THE INCIDENTS OCCURRED TO THE SAME PATIENT. THERE WAS NO PERMANENT HARM TO ANY OF THE PATIENTS, BUT ONE PATIENT EXPERIENCED THE FOLLOWING DUE TO THE DETACHMENT OF THE NEOBAR "BAR": PATIENT WAS COUGHING AND GAGGING ON SECRETIONS AND ETT AND NEOBAR BECAME LOOSE. THE RT IN ROOM WITH NURSE RETAPED NEOBAR, BUT PATIENT WAS GASPING AND COUGHING DUE TO LOW VOLUME ON VENT, SO REMOVED ETT AND PAGED ANESTHESIA TO REINTUBATE. NICU ATTENDING CAME OVER TO ASSIST, AND INTUBATED PATIENT WITH 4.0 ETT. PATIENT WAS BAGGED DURING ENTIRE EVENT, NO LOC, BRADY AND DESAT INITIALLY, AND RECOVERED. THE 2ND PATIENT SELF EXTUBATED IN ONE INCIDENT, BUT WAS DISCOVERED AND WAS NOT HARMED. ALL NEOBARS OF THAT LOT NUMBER WERE PULLED FROM STOCK AND REPLACEMENTS HAVE ALREADY ARRIVED FROM THE NEOTECH PLANT. ACCORDING TO ANECDOTAL INFORMATION ON A LIST SERVE, AT LEAST 2 OTHER FACILITIES HAVE REPORTED THE SAME ISSUE. NO OTHER PROBLEMS HAVE BEEN REPORTED WITH THE NEW LOT OF GRAY NEOBARS, HOWEVER, ONLY ONE HAS BEEN PUT TO USE SO FAR. IT IS RECOMMENDED THAT THIS LOT NUMBER BE EVALUATED FOR A NATIONWIDE RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOBAR ENDOTRACHEAL TUBE BTR NEOTECH PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other