BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-THRU INTRALUMINAL SHUNT

    MDR report key: 3090034 · Received May 2, 2013

    Report

    Report Number
    2032282-2013-00037
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    December 20, 2012
    Report Date
    April 22, 2013
    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 MATERIAL IN THE PRODUCT POUCH WAS OBVIOUSLY IDENTIFIED PRIOR TO USE, SO IN THIS CASE THERE WAS NO POSSIBLE HARM OR INJURY TO PATIENT. IF SUCH TYPE OF MALFUNCTION OR HAZARD WOULD REOCCUR AND USER WILL NOT RECOGNIZE A 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, STERILE VASCULAR INFLAMMATION, OR THROMBOTIC REACTION, WHICH ONLY IN EXCEPTIONAL CASES MAY CAUSE SERIOUS HARM OR INJURY. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF THE INVESTIGATION RESULTS OF THE SAMPLE.

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION OF THE THREE COMPLAINT SAMPLES BY BAXTER SYNOVIS CONFIRMED THE PRESENCE OF FIBERS. PARTICULATE ANALYSIS WAS PERFORMED BY BAXTER (B)(4). EXAMINATION OF COMPLAINT SAMPLE ONE REVEALED THE PRESENCE OF TWO FIBERS: ONE RED/ORANGE FIBER (APPROX. 1.5MM IN LENGTH) WAS OBSERVED ON THE DEVICE TAB WITHIN THE SECOND LAYER OF PACKAGING (NO DIRECT CONTACT WITH DEVICE) AND WAS CONSISTENT WITH MERCERIZED COTTON; THE SECOND ONE WAS A BLACK FIBER (1.0MM) AND LOCATED IN THE FIRST LAYER OF PACKAGING AND WAS IDENTIFIED AS COTTON. FOR COMPLAINT SAMPLE TWO, A GREEN FIBER (APPROX. 0.7MM IN LENGTH) WAS DETERMINED TO BE COTTON AND WAS OBSERVED ON THE DEVICE TAB. THE THIRD SAMPLE IDENTIFIED A BROWN FIBER (APPROX. 1.4MM IN LENGTH) THAT WAS DETECTED BETWEEN THE INNER AND OUTER POUCHES (NO DIRECT CONTACT WITH DEVICE) AND IDENTIFIED AS PAPER FIBER. 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 NONCONFORMITIES, FAILURES, REWORK OR DEVIATIONS DOCUMENTED IN THE BATCH RECORD THAT COULD BE ASSOCIATED WITH THE REPORTED PROBLEM. 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. CAPA- 00844 IS CURRENTLY OPEN TO FURTHER INVESTIGATE PARTICULATE MATTER ISSUES FOR THIS PRODUCT. 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 WITHIN THE FLO-THRU. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192413 FLO-THRU INTRALUMINAL SHUNT CLAMP, VASCULAR DXC SYNOVIS SURGICAL INNOVATIONS SPCE312-NOV0007

    Patients

    Seq Age Sex Outcome Treatment
    1