BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-THRU

    MDR report key: 6199859 · Received December 22, 2016

    Report

    Report Number
    1416980-2016-18668
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Report Date
    January 27, 2017
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    DXC
    PMA / PMN Number
    K981624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IN THE INITIAL MDR IS BEING CORRECTED TO (B)(4) 2016. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OCCURRED SOMETIME IN (B)(6) 2016. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLO-THRU HAD PARTICULATE MATTER IN THE INNER OVERPOUCH. THIS WAS OBSERVED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850962 FLO-THRU CLAMP, VASCULAR DXC SYNOVIS SURGICAL INNOVATIONS NA SP16F291163850

    Patients

    Seq Age Sex Outcome Treatment
    1