BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    105ADMIN SET 20DP, W/2 Y SITE, CV CLMPS

    MDR report key: 10242928 · Received July 7, 2020

    Report

    Report Number
    9616066-2020-02190
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 3, 2020
    Report Date
    June 12, 2020
    Manufacturer
    CFN MEXICO 215 SA DE CV
    Product Code
    FPA
    UDI-DI
    00814371020198
    PMA / PMN Number
    K132841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 07/15/2020. E1:CONTACT INFORMATION FOR INITIAL REPORTER WAS UPDATE TO (B)(6). E3. OCCUPATION: QUALITY ASSURANCE ENGINEER. G3: REPORT SOURCE: USER FACILITY, OTHER. G3: QUALITY ASSURANCE ENGINEER. INVESTIGATION SUMMARY: A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED. BD PRODUCT MODEL: B2-70072, REPORTED LOT NUMBER: 19105051. GRAVITY TESTING WAS CONDUCTED BY CAD SD ON THE THREE B2-70072, WITH THE PRIMARY SETS PRIMED WITH WATER, AND THE SECONDARY SETS PRIMED WITH BLUE-DYE WATER, UPON CLAMPING THE PRIMARY SET, BACKFLOW WAS OBSERVED IN ALL THE SETS, CONFIRMING THE FAILURE MODE. THE VALVE CHECK REPORTED WAS MANUFACTURED AT A SUPPLIER SITE. THEREFORE, A FORMAL INVESTIGATION WAS REQUESTED TO THE SUPPLIER: THE COMPLAINT WAS ACKNOWLEDGED BY FILTERLEAK ON AUG/05/2020. WHEN THE COMPLAINT WAS RECEIVED FILTERTEK NEWCASTLE WEST WAS CLOSED FOR SUMMER SHUTDOWN. PLANT REOPENED ON AUG/18/2020. PART NUMBER: 8300219, LOT: 20706 WAS PRODUCED, IN FILTERTEK NEWCASTLE WEST FROM JUL/10/2018 TO JUL/26/2018. THE ENTIRE LOT QUANTITY, (B)(4) PARTS WERE SHIPPED TO ITW MEDICAL HEBRON FOR LATER SHIPMENT TO BD. THE BATCH RECORD NO ISSUES NOTED AS PART OF THE MANUFACTURE OR QC TESTING OF LOT: 20706. FIVE RETAINED PARTS FROM THE START-UP OF THE LOT WERE BACKFLOW TESTED ¿ ALL PASSED; NO PREVIOUS COMPLAINTS RECEIVED FOR LOT: 20706. THE SAMPLES WERE DELIVERED BY FEDEX ON (B)(6) 2020. THE RETURNED CHECK VALVES WERE INCLUDED IN SETS NUMBERED B1, B2 & B3. SAMPLE B1: THE CHECK VALVE FAILED TO SHUT OFF WHEN A SECONDARY IV LINE WAS INTRODUCED, FLUID WAS SEEN TO TRAVEL FROM THE SECONDARY LINE BACK THROUGH THE CHECK VALVE, CONFORMING BD¿S REPORTED BACKFLOW LEAK. ON REMOVING THE VALVE FROM THE SET A MANUAL BACKFLOW TEST AND OPENING PRESSURE TEST WERE COMPLETED, THE VALVE FAILED THE BACKFLOW TEST (FAST LEAK) AND THE OPENING PRESSURE WAS LOW AT 2 CMWG. SAMPLE B2: THE CHECK VALVE PREVENTED A BACKFLOW FROM OCCURRING WHEN A SECONDARY IV LINE WAS INTRODUCED. ON REMOVING THE VALVE FROM THE SET A MANUAL BACKFLOW TEST AND OPENING PRESSURE TEST WERE COMPLETED, THE VALVE PASSED THE BACKFLOW TEST AND THE OPENING PRESSURE WAS 7 CM. THE VALVE WAS SECTIONED, AND THE INTERNALS WERE CLEAN. SAMPLE B3: B3: THE CHECK VALVE PREVENTED A BACKFLOW FROM OCCURRING WHEN A SECONDARY IV LINE WAS INTRODUCED. ON REMOVING THE VALVE FROM THE SET A MANUAL BACKFLOW TEST AND OPENING PRESSURE TEST WERE COMPLETED, THE VALVE PASSED THE BACKFLOW TEST AND THE OPENING PRESSURE WAS 6 CM. THE VALVE WAS SECTIONED AND THE INTERNALS WERE CLEAN. THE BACKFLOW ISSUES FOUND IN SAMPLE B2 & B3 COULD NOT BE REPLICATED IN FILTERTEK. THE ISSUE WAS REPLICATED BY FILTERTEK AND TRANSLUCENT PARTICLES WERE FOUND IN THE PART B1 WHEN IT WAS SECTIONED. ALTHOUGH IT CANNOT BE CONFIRMED THAT THE TRANSLUCENT PARTICLES WERE THE CAUSE OF THE BACKFLOW, THEY WERE FOUND IN THE PART WITH THE BACKFLOW AND NOT IN THE TWO OTHER RETURNED PARTS. THERE ARE NO SOURCES OF STARCH USED IN THE FILTERTEK MANUFACTURING PROCESS. AS NO CONCLUSIVE ROOT CAUSE HAS BEEN FOUND THERE NO ACTIONS APPLICABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 105 ADMIN SET 20DP, W/2 Y SITE, CV CLMPS HAD BACK FLOW ISSUES. THIS OCCURRED ON 7 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: B2-70072, BATCH (LOT) NO: 19105051. IT WAS REPORTED THAT ADMINISTRATION SETS HAD BACK FLOW ISSUES.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 105ADMIN SET 20DP, W/2 Y SITE, CV CLMPS HAD BACK FLOW ISSUES. THIS OCCURRED ON 7 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: B2-70072 BATCH(LOT) NO: 19105051. IT WAS REPORTED THAT ADMINISTRATION SETS HAD BACK FLOW ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702645 105ADMIN SET 20DP, W/2 Y SITE, CV CLMPS INTRAVASCULAR ADMINISTRATION SET FPA CFN MEXICO 215 SA DE CV B2-70072 19105051 00814371020198

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200603.| 20200603.