BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON BACTERIAL/VIRAL FILTER

    MDR report key: 5416890 · Received February 8, 2016

    Report

    Report Number
    8040412-2016-00030
    Event Type
    Malfunction
    Date Received
    February 8, 2016
    Date of Event
    February 4, 2016
    Report Date
    February 4, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT# HAS BEEN CORRECTED TO 201541. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE FILTER WAS DETACHED. IT WAS ALSO NOTICED THAT THE RIB WAS BROKEN FROM THE HOUSING OF THE FILTER. THIS MOST LIKELY CAUSED BY MISHANDLING OF THE PRODUCT. IN THE CURRENT MANUFACTURING PROCESS, A 100% INSPECTION IS CONDUCTED AT THE ASSEMBLY AND PACKAGING AREA, THUS ANY DEFECTS WOULD BE DETECTED PRIOR TO RELEASE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE FILTER CAME APART DURING USE. NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE FILTER CAME APART DURING USE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75526 HUDSON BACTERIAL/VIRAL FILTER BREATHING CIRCUIT BACTERIAL FILTER CAH TELEFLEX MEDICAL 201541

    Patients

    Seq Age Sex Outcome Treatment
    1