BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIFURCATED EXT SET

    MDR report key: 10425515 · Received August 19, 2020

    Report

    Report Number
    2245270-2020-00073
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Date of Event
    August 3, 2020
    Report Date
    September 24, 2020
    Manufacturer
    VYGON USA
    Product Code
    FPA
    PMA / PMN Number
    K021395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE TWELVE (12) OCCURRENCES OF THIS ISSUE, THE DETAILS FOR THE EVENTS CAN BE FOUND IN THE FOLLOWING REPORTS: 2245270-2020-00073, 2245270-2020-00074, 2245270-2020-00075, 2245270-2020-00076, 2245270-2020-00077, 2245270-2020-00078, 2245270-2020-00079, 2245270-2020-00080, 2245270-2020-00081, 2245270-2020-00082, 2245270-2020-00083, 2245270-2020-00084. TWO HUNDRED AND FOUR (204) UNOPENED SAMPLES WERE RETURNED TO VYGON FOR EVALUATION. TWELVE (12) SAMPLES FOR LOT 1908008W AND ONE HUNDRED AND NINETY-TWO (192) FOR LOT 1908009W. A VISUAL INSPECTION OF THE SETS REVEALED NO OBVIOUS PHYSICAL DEFECTS. THE TWELVE (12) SAMPLES FOR LOT 1908008W UNDERWENT LEAK AND OCCLUSION TESTING AND ONE SET FAILED THE LEAK TEST. A FUNCTIONAL TEST WAS PERFORMED BY ATTACHING A 10ML SYRINGE OF SODIUM CHLORIDE TO THE PROXIMAL END OF THIS SET AND PRESSURIZING THE SET TO HELP DETERMINE THE ACTUAL LOCATION OF THE LEAKAGE. THE LEAKAGE WAS FOUND AT BIFURCATED CONNECTOR. THIS COMPLAINT IS CONFIRMED. THE FIFTEEN (15) SAMPLES FOR LOT 1908009W UNDERWENT LEAK AND OCCLUSION TESTING AND PASSED BOTH TESTS. THIS COMPLAINT COULD NOT BE CONFIRMED AS NO OCCLUSIONS AND NO LEAKS WERE OBSERVED. OUT OF 27 SETS, TWENTY-SIX SETS PASSED BOTH TESTS THEREFORE, THIS COMPLAINT COULD NOT BE CONFIRMED FOR THE 26 SETS. A TWO-YEAR REVIEW OF THE COMPLAINTS DATA SHOWS NO OTHER COMPLAINTS AGAINST THE AMS-520 PRODUCT. ROOT CAUSE: THESE LOTS WERE MANUFACTURED BY DRAGON HEART. (B)(4) TO INVESTIGATE AND RESOLVE THIS ISSUE. CORRECTIVE ACTION: (B)(4) HAS BEEN ISSUED TO DRAGON HEART TO INVESTIGATE AND RESOLVE THIS ISSUE.

    Description of Event or Problem · 0

    THERE ARE SIGNIFICANT PRODUCT LEAKAGES.

    Additional Manufacturer Narrative · 1

    THE FAILED SAMPLES WILL BE RETURNED TO VYGON AND WILL BE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED WITH FDA WITHIN 30 DAYS OF COMPLETION. THERE WERE TWELVE (12) OCCURRENCES OF THIS ISSUE, THE DETAILS FOR THE EVENTS CAN BE FOUND IN THE FOLLOWING REPORTS: 2245270-2020-00074, 2245270-2020-00075, 2245270-2020-00076, 2245270-2020-00077, 2245270-2020-00078, 2245270-2020-00079, 2245270-2020-00080, 2245270-2020-00081, 2245270-2020-00082, 2245270-2020-00083, 2245270-2020-00084.

    Description of Event or Problem · 1

    THERE ARE SIGNIFICANT PRODUCT LEAKAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890797 BIFURCATED EXT SET INTRAVASCULAR ADMIN SE FPA VYGON USA AMS-520 1908009W

    Patients

    Seq Age Sex Outcome Treatment
    1