BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON TRACH ADAPTOR

    MDR report key: 6109250 · Received November 17, 2016

    Report

    Report Number
    8040412-2016-00262
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    November 11, 2016
    Report Date
    November 11, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCOMPLETE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IN THE CURRENT MANUFACTURING PROCEDURE, 100% LEAK TESTING IS CONDUCTED AT THE ASSEMBLY AREA; THEREFORE, A DEFECT OF THIS TYPE WOULD BE DETECTED PRIOR TO RELEASE. TEN SAMPLES WERE SELECTED FROM CURRENT PRODUCTION AT THE MANUFACTURING FACILITY AND INSPECTED. NO DEFECTS WERE FOUND ON THE SAMPLES. THEY ALL PASSED A VISUAL EXAM AND LEAK TESTING. IF THE SAMPLE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE TUBING HAS A SMALL TEAR AT THE CONNECTION POINT CLOSEST TO THE PATIENT'S END.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE TUBING HAS A SMALL TEAR AT THE CONNECTION POINT CLOSEST TO THE PATIENT'S END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760804 HUDSON TRACH ADAPTOR AIRWAY CONNECTOR BZA TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1