BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER, ADAPTORS 033

    MDR report key: 2152509 · Received June 21, 2011

    Report

    Report Number
    1417411-2011-00074
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 17, 2011
    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

    THE DEVICE SAMPLE WAS NOT REC'D BY THE MFR AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGED ISSUE: "THE WATER LEAK WAS FOUND AT THE CONNECTION OF RETURN TUBE TO THE ADAPTOR." DEFECT WAS DISCOVERED DURING USE ON A PT RECEIVING NEBULIZATION TREATMENT. 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK