BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEBULIZER W/TEE

    MDR report key: 2180799 · Received April 29, 2011

    Report

    Report Number
    3004365956-2011-00178
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 3, 2011
    Report Date
    April 5, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT BEEN RECEIVED BY MFR. THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES THAT THE NEBULIZER CUP IS NOT TIGHT AND THE FLUID LEAKS. FOUND PRIOR TO USE ON A PT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEBULIZER W/TEE NEBULIZER CAF TELEFLEX MEDICAL 02C1001040

    Patients

    Seq Age Sex Outcome Treatment
    1