BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-THRU

    MDR report key: 4996752 · Received August 12, 2015

    Report

    Report Number
    1416980-2015-32166
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Report Date
    October 5, 2015
    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

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. MICROSCOPIC INSPECTION REVEALED A COLORLESS MASS, 0.5 MM BY 0.4 MM IN SIZE, ON THE DEVICE SHAFT. PHYSICAL PROPERTIES OF THE MASS WERE CONSISTENT WITH ROOM TEMPERATURE VULCANIZATION SILICONE ADHESIVE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION NOT DETERMINED. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE EVENT WAS REPORTED TO HAVE OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2015. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER IN THE INNER POUCH OF A FLO-THRU DEVICE. THIS WAS NOTED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528325 FLO-THRU CLAMP, VASCULAR DXC SYNOVIS SURGICAL INNOVATIONS SP15F091054787

    Patients

    Seq Age Sex Outcome Treatment
    1