BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE

    MDR report key: 3966560 · Received June 26, 2014

    Report

    Report Number
    3004365956-2014-00238
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 12, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS RECEIVED BY THE MFR, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT. TWO PICTURES OF THE UNIT OF CATALOG NUMBER 031-332 (NEBULIZER ADAPTOR 033, STERILE, (B)(6)) WERE RECEIVED FOR ANALYSIS. THEY WERE VISUALLY INSPECTED FOUNDING THE RETURN TUBE (B)(6) DISASSEMBLED OF THE NEBULIZER BASE. FROM THE PICTURES, IT'S NOT CLEARLY VISUALIZED IF THE RETURN TUBE CONTAINS GLUE RESIDUE WHICH IS USED TO ATTACH THE NEBULIZER BASE TO THE TUBE. A DHR (DEVICE HISTORY RECORD) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE RETURN TUBE FELL OFF WHILE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373904 HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE NEBULIZER ADAPTOR CCQ TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1