BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL CIRCUIT, DUAL HTD LIMB, 60 IN

    MDR report key: 2771651 · Received September 26, 2012

    Report

    Report Number
    3004365956-2012-00292
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 18, 2012
    Manufacturer
    TELEFLEX
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNK. THE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS FOUND THAT THE INSPIRATORY LIMB HAD THREE DENTS IN THE CORRUGATE AT 2-INCHES, 4-INCHES, AND 8-INCHES FROM THE PT WYE. THESE WERE DENTS AND NOT MELTS IN THE TUBING AS REPORTED IN THE COMPLAINT. THE DENTS WERE FROM THE OUTSIDE PUSHING IN AND WERE NOT FROM HEATING INSIDE THE TUBING. THE EXPIRATORY LIMB HAD NO NOTICEABLE DEFECTS. THE RESISTANCE OF BOTH INSPIRATORY AND EXPIRATORY WIRES WERE MEASURED AND FOUND TO BE WITHIN THE ALLOWABLE RANGE. BASED ON THE INVESTIGATION PERFORMED, THE COMPLAINT OF MELTED CIRCUIT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES THAT THE CIRCUIT MELTED IN FOUR LOCATIONS ON THE INSPIRATORY CIRCUIT. PT AIRWAY TEMPERATURE SAID TO BE AT 37 DEGREES WITH NORMAL CONDENSATION IN THE CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEONATAL CIRCUIT, DUAL HTD LIMB, 60 IN NEONATAL HEATED WIRE CIRCUIT BZO TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1