BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L CONNECTOR C90J

    MDR report key: 9898410 · Received March 30, 2020

    Report

    Report Number
    3003152976-2020-00149
    Event Type
    Malfunction
    Date Received
    March 30, 2020
    Date of Event
    March 6, 2020
    Report Date
    May 19, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    LHI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SAMPLE AND ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED AND A LEAKAGE AROUND THE MEMBRANE WAS OBSERVED. IT WAS NOTED THAT THE MEMBRANE WAS INCORRECTLY POSITIONED AND WELDED ONTO THE CONNECTOR HOUSING, RESULTING IN THE LEAKAGE REPORTED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOTS 1908107, 1909103 AND 1910105, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THREE RETAINED SAMPLES OF EACH LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED, THE MEMBRANE WAS PROPERLY PLACED AND WELDED ONTO THE CONNECTOR HOUSING, AND NO LEAKAGE OCCURRED. PRODUCT UNDERGOES A SERIES OF VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT MANUFACTURING, INCLUDING VERIFICATION THAT THE CONNECTOR MEMBRANE IS PROPERLY WELDED AND LEAKAGE TESTING. ALL TESTING WAS REVIEWED FOR THE REPORTED LOT AND NO ISSUES WERE IDENTIFIED RELATED TO THIS MALFUNCTION. A VISION SYSTEM IS USED TO VERIFY THE PROPER POSITIONING AND WELDING OF THE MEMBRANE, REJECTING ANY DEFECTIVE PRODUCT IDENTIFIED, ALL SYSTEMS WERE PROPERLY VALIDATED PRIOR TO THE MANUFACTURING OF THIS LOT. TO CHALLENGE THE VISION SYSTEM, WE PLACED THE DECONTAMINATED CONNECTOR SAMPLE IN THE ASSEMBLY STATIONS AND THE DEFECTIVE PRODUCT WAS PROPERLY DETECTED AND REJECTED. THE PROCESS OF PLACING THE MEMBRANE IS PERFORMED MANUALLY. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT OCCURRED DUE TO BOTH AN ISOLATED INCIDENT PERFORMED BY THE OPERATOR THAT RESULTED IN THE IMPROPER WELDING OF THE MEMBRANE AND THE VISION SYSTEM NOT PROPERLY DETECTING AND REJECTING THE PRODUCT. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT. A PROJECT HAS BEEN INITIATED TO INPUT A MORE ENHANCED VISION SYSTEM TO DETECT THESE DEFECTS. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT L CONNECTOR C90J LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PREPARING DOXORUBICIN, DRUG LEAKED FROM AROUND THE OUTSIDE OF THE MEMBRANE. HCP HANDLED THE DEVICES AS USUAL. CUSTOMER REQUESTED TO INVESTIGATE THE ISSUE ASAP. BECAUSE THE SAME ISSUE OCCURRED LAST YEAR."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 L CONNECTOR C90J LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PREPARING DOXORUBICIN, DRUG LEAKED FROM AROUND THE OUTSIDE OF THE MEMBRANE. HCP HANDLED THE DEVICES AS USUAL. CUSTOMER REQUESTED TO INVESTIGATE THE ISSUE ASAP. BECAUSE THE SAME ISSUE OCCURRED LAST YEAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359761 L CONNECTOR C90J CLOSED SYSTEM TRANSFER DEVICE LHI BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other