BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK LEAKED

    MDR report key: 7970080 · Received October 16, 2018

    Report

    Report Number
    9610847-2018-00335
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    September 21, 2018
    Report Date
    November 12, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER: 8010922. OUR RECORDS SHOW THE REPORTED LOT WAS MANUFACTURED ON JANUARY 31, 2018, AND DETERMINED THAT THIS IS THE ONLY INSTANCE OF LEAKAGE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS OF PACKAGED GOODS. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING, WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BASED ON INVESTIGATION RESULTS, THE ROOT CAUSE WAS NOT IDENTIFIED BECAUSE THE CUSTOMER DID NOT PROVIDE THE SUFFICIENT INFORMATION (SAMPLE OR PICTURE) WHICH IS ESSENTIAL TO PERFORM A BETTER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD CONNECTA¿ STOPCOCK LEAKED. THERE WAS NOT REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    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 A BD CONNECTA¿ STOPCOCK LEAKED. THERE WAS NOT REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812138 BD CONNECTA¿ STOPCOCK LEAKED STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8010922

    Patients

    Seq Age Sex Outcome Treatment
    1 Other