BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-THRU INTRALUMINAL SHUNT

    MDR report key: 2912132 · Received January 11, 2013

    Report

    Report Number
    2032282-2013-00005
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 25, 2012
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    DXC
    PMA / PMN Number
    K981624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THE FOREIGN BODY IN THE PRODUCT POUCH WAS OBVIOUSLY IDENTIFIED PRIOR TO USE, SO IN THIS CASE THERE WAS NO POSSIBLE HARM OR INJURY OF PATIENT. IF SUCH TYPE OF MALFUNCTION OR HAZARD WOULD RECUR AND USER DID NOT RECOGNIZE THE FOREIGN BODY PRIOR TO USE, IT POSSIBLY CAN BE TRANSFERRED TO THE TREATMENT SITE OF THE PATIENT. IN A WORST CASE SCENARIO, THIS MAY LEAD TO A FOREIGN BODY REACTION AND STERILE VASCULAR INFLAMMATION OR THROMBOTIC REACTION WHICH ONLY IN EXCEPTIONAL CASES MAY CAUSE SERIOUS HARM OR INJURY. ADDITIONAL INVESTIGATION IS CURRENTLY ONGOING AND THE SAMPLE HAS BEEN REQUESTED FOR EVALUATION. UPON ITS COMPLETION A FOLLOW-UP SUBMISSION WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION OF THE COMPLAINT SAMPLE BY BAXTER SYNOVIS OBSERVED A COLORLESS FIBER WITH IRREGULARLY SHAPED BLACK PARTICLES (LESS THAN 0.1MM) ADHERED TO THE FIBER BETWEEN THE INNER AND OUTER POUCHES (NO DIRECT CONTACT WITH DEVICE). PARTICULATE ANALYSIS BY BAXTER ROUND LAKE IDENTIFIED THE COLORLESS FIBER AS COTTON (APPROX.0.7MM) WITH SILICONE OIL. THE BLACK FIBERS COULD NOT BE DEFINITIVELY IDENTIFIED. THE COMPLAINT WAS CONFIRMED. BATCH RECORD REVIEW BY BAXTER SYNOVIS FOUND NO ISSUES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. ALL PRODUCT REQUIREMENTS WERE MET AND THE LOT PASSED ALL INSPECTIONS. THERE WERE NO ISSUES AND NO SCRAP REPORTED. PER BAXTER SYNOVIS, THE PRODUCT IS INSPECTED FOR FOREIGN MATERIAL AT THREE POINTS DURING MANUFACTURE. NO TREND WAS IDENTIFIED. BAXTER SYNOVIS DETERMINED THAT NO MANUFACTURING DEFECT WAS FOUND, THE ROOT CAUSE IS INDETERMINABLE, AND THE ISSUE IS CONSIDERED LOW RISK. PER ADDITIONAL INFORMATION RECEIVED FROM BAXTER SYNOVIS, (B)(4) HAS BEEN INITIATED TO FURTHER INVESTIGATE PARTICULATE MATTER ISSUES. THIS IS THE FIRST REPORTED COMPLAINT OF THIS NATURE FOR THIS PRODUCT LOT. THE COMPLAINT WILL BE KEPT ON FILE FOR TRENDING PURPOSES

    Description of Event or Problem · 1

    CUSTOMER REPORTED: WE HAVE FOUND FOREIGN MATTER IN POUCHES OF FLO-THRU. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18066 FLO-THRU INTRALUMINAL SHUNT CLAMP, VASCULAR DXC SYNOVIS SURGICAL INNOVATIONS 5801473-1830328

    Patients

    Seq Age Sex Outcome Treatment
    1