BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON BREATHING CIRCUIT, F-STYLE, ADULT, 60"

    MDR report key: 2062434 · Received March 18, 2011

    Report

    Report Number
    3004365956-2011-00095
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 22, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY MANUFACTURER, HOWEVER, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THERE WAS A SMALL HOLE IN THE CONNECTOR OF THE CIRCUIT. IT WAS FOUND AT THE SET UP. DEFECT WAS DISCOVERED DURING INSPECTION/FUNCTIONALITY TESTING PRIOR TO USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON BREATHING CIRCUIT, F-STYLE, ADULT, 60" BREATHING CIRCUIT BZO TELEFLEX MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1