BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ADULT CONVENTIONAL BREATHING CIRCUIT

    MDR report key: 2934766 · Received January 23, 2013

    Report

    Report Number
    3004365956-2013-00029
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 7, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR (DEVICE HISTORY RECORD) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DHR ALSO SHOWED THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. NO NON CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. THE SAMPLE WAS REC'D BY THE MFR, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE CIRCUIT WOULD NOT PASS THE LEAK TEST DURING TESTING. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33231 HUDSON ADULT CONVENTIONAL BREATHING CIRCUIT BREATHING CIRCUIT CAI TELEFLEX MEDICAL 02H1202826

    Patients

    Seq Age Sex Outcome Treatment
    1