BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON VENTILATOR TUBING SET, LONG LENGTH

    MDR report key: 3063695 · Received April 12, 2013

    Report

    Report Number
    3004365956-2013-00121
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 18, 2013
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD OF LOT NUMBER 02H1201519 HAS BEEN REVIEWED AND THERE WERE NO ISSUES OR DISCREPANCIES FOUND WHICH COULD POTENTIALLY RELATE TO THE REPORTED COMPLAINT. THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. THE ASSEMBLY PROCESS AND MANUFACTURING PROCEDURE FOR PRODUCT CODE 1613 WERE REVIEWED AND THERE WERE NO ISSUES FOUND. THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: "PLASTIC PLUG INSERTED INTO TEMPERATURE PROBE PORT WILL NOT HOLD PRESSURE - IT POPS OFF." THE REPORTED ISSUE WAS DETECTED PRIOR TO PATIENT USE, DURING FUNCTIONALITY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159571 HUDSON VENTILATOR TUBING SET, LONG LENGTH VENTILATOR TUBING SET BTR TELEFLEX 02H1201519

    Patients

    Seq Age Sex Outcome Treatment
    1