BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON HUMID-VENT FILTER COMPACT STR STERILE

    MDR report key: 3966539 · Received June 26, 2014

    Report

    Report Number
    8040412-2014-00148
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 13, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE REPORTED ISSUE WAS DETECTED/REPORTED BY DISTRIBUTOR (IMJ). THE REPORTED ISSUE WAS DETECTED/REPORTED BY DISTRIBUTOR ((B)(4)). A TOTAL OF FOUR DEVICES WERE REPORTED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373900 HUDSON HUMID-VENT FILTER COMPACT STR STERILE H-V FILTER CAH TELEFLEX MEDICAL 13KT11J

    Patients

    Seq Age Sex Outcome Treatment
    1