BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER ADAPTER, STERILE, 033

    MDR report key: 2061502 · Received March 15, 2011

    Report

    Report Number
    1417411-2011-00034
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    September 14, 2010
    Report Date
    February 2, 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

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, 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: A PIN HOLE IN THE PACKAGE WAS FOUND DURING INCOMING INSPECTION. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEBULIZER ADAPTER, STERILE, 033 NEBULIZER ADAPTOR CAF TELEFLEX MEDICAL NA E10033

    Patients

    Seq Age Sex Outcome Treatment
    1