BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D 2SS CV

    MDR report key: 12027231 · Received June 18, 2021

    Report

    Report Number
    2243072-2021-01711
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    February 28, 2021
    Report Date
    September 14, 2021
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT AN AS LVP 20D 2SS CV EXPERIENCED FLOW ISSUES AND A CHECK VALVE MALFUNCTION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "CHECK VALVE FAILED BACKFLOW TESTING" MEDICAL DEVICE BRAND NAME: AS LVP 20D 2SS CV CATALOG #: 2420-0007. UDI #: (B)(4). PMA / 510(K)#: K944320. DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2021-06-01. INVESTIGATION SUMMARY ONE SAMPLE WAS RETURNED BY THE CUSTOMER AND INVESTIGATED. IT WAS REPORTED THAT DURING THE INVESTIGATION THE CHECK VALVE FAILED BACKFLOW TESTING. A QUALITY NOTIFICATION HAS BEEN SENT TO THE SUPPLIER, AND THE SAMPLE HAS BEEN SENT FOR FURTHER INVESTIGATION. THE SUPPLIER WAS ABLE TO CONFIRM BACK FLOW. THE CHECK VALVE WAS CENTERED. THE SAMPLE PASSED THE WELD INTEGRITY AND ASSEMBLY CHARACTERISTICS INSPECTION. THE SAMPLE WAS DISASSEMBLED AND PARTICULATE WAS FOUND ON THE DIAPHRAGM. THE PARTICULATE WAS SENT FOR ANALYSIS, AND WAS IDENTIFIED AS GELATIN/PROTEIN. THESE MATERIALS ARE NOT USED IN THE DESIGN OF THE CHECK VALVE. THE PARTICULATE COULD HAVE POSSIBLY CONTRIBUTED TO THE BACKFLOW, THOUGH IT IS UNCLEAR FROM WHERE THE PARTICULATE ORIGINATED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 2420-0007 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN AS LVP 20D 2SS CV EXPERIENCED FLOW ISSUES AND A CHECK VALVE MALFUNCTION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "CHECK VALVE FAILED BACKFLOW TESTING".

    Additional Manufacturer Narrative · 1

    "UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD DEVICE EXPERIENCED FLOW ISSUES AND A CHECK VALVE MALFUNCTION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "CHECK VALVE FAILED BACKFLOW TESTING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923180 AS LVP 20D 2SS CV INTRAVASCULAR ADMINISTRATION SET FPA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1