BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON VENTILATOR TUBING SET,LONG LENGTH

    MDR report key: 12921164 · Received December 2, 2021

    Report

    Report Number
    3004365956-2021-00314
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 1, 2021
    Report Date
    November 9, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAI
    UDI-DI
    14026704658920
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#: (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. ONE PHOTO OF CATALOG NUMBER 1613 (VENTILATOR TUBING SET, LONG LENGTH) LOT 74D2001235 WAS RECEIVED FOR ANALYSIS FROM THE CUSTOMER. IT ONLY SHOWS A PART OF CIRCUIT WHERE THE WYE P/N 12138-02 AND CLOSURE P/N 30536) ARE LOCATED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED "I HAVE HAD A FEW COMPLAINTS OVER THE LAST COUPLE OF WEEKS REGARDING OUR VENTILATOR CIRCUITS (REF: 1613).THE CONNECTOR PLUGS BECOME DISCONNECTED FROM THE TEMPERATURE PROBE PORTS". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817633 HUDSON VENTILATOR TUBING SET,LONG LENGTH CIRCUIT, BREATHING (W CONNECTO CAI TELEFLEX MEDICAL IPN913687 74D2001235 14026704658920

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown