BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON HUMID-VENT FILTER COMPACT STR STERILE

    MDR report key: 3851585 · Received March 25, 2014

    Report

    Report Number
    8040412-2014-00075
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 5, 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 RETURNED TO THE MFR, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER REPORTS THAT THE PACKAGE IS TORN. THE REPORTED ISSUE WAS DETECTED DURING INCOMING INSPECTION BY THE DIST (IMJ). A TOTAL OF FOUR DEVICES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174218 HUDSON HUMID-VENT FILTER COMPACT STR STERILE H-V FILTER CAH TELEFLEX MEDICAL 13JT03J

    Patients

    Seq Age Sex Outcome Treatment
    1