BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER ADAPTORS, 033

    MDR report key: 2102942 · Received May 11, 2011

    Report

    Report Number
    1417411-2011-00048
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 19, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE RECEIVED BY MFR, BUT INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: THERE WAS WATER LEAKING AT THE CONNECTION OF THE RETURN TUBE AND THE DEFECT WAS DISCOVERED DURING A NEBULIZATION TREATMENT. NO MEDICAL INTERVENTION WAS NECESSARY. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEBULIZER ADAPTORS, 033 NEBULIZER ADAPTOR CAF TELEFLEX MEDICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK