BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CRITICAL CARE NEBULIZER ADAPTOR 033

    MDR report key: 1898209 · Received October 25, 2010

    Report

    Report Number
    1417411-2010-00043
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    August 20, 2010
    Report Date
    October 7, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    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 MFR, HOWEVER, THE 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: THE YELLOW WINGNUT CONNECTOR OF THE ADAPTOR WAS FOUND TO BE UNSTABLE AND THUS COULD NOT NEBULIZE PROPERLY. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON CRITICAL CARE NEBULIZER ADAPTOR 033 NEBULIZER ADAPTOR CAF TELEFLEX MEDICAL NA J10933

    Patients

    Seq Age Sex Outcome Treatment
    1