BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON/GILBECK ISO-GARD FILTER ANGLED

    MDR report key: 3900269 · Received May 1, 2014

    Report

    Report Number
    8040412-2014-00098
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    February 27, 2014
    Report Date
    April 17, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE FILTER FAIL APART DURING USE. A NEW FILTER WAS USED WITHOUT INCIDENT. NO PATIENT INJURY/HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262255 HUDSON/GILBECK ISO-GARD FILTER ANGLED BACTERIAL/VIRALFILTER CAH TELEFLEX MEDICAL 201330

    Patients

    Seq Age Sex Outcome Treatment
    1