BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿¿ PLUS STOPCOCK WITH 4-WAY 360° TAP ROTATION AND WHITE TAB

    MDR report key: 8019828 · Received October 30, 2018

    Report

    Report Number
    9610847-2018-00365
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 8, 2018
    Report Date
    November 14, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 6060753. OUR RECORDS SHOW THE REPORTED LOT WAS MANUFACTURED ON 03/06/2016, AND DETERMINED THAT THIS IS THE FIRST INSTANCE OF THIS ISSUE 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 DEVELOPED, THE NOGALES TEAM CANNOT CONFIRM THE DEFECT BECAUSE FOR THIS SPECIFIC COMPLAINT, THE CUSTOMER DIDN¿T PROVIDE SAMPLE FOR EVALUATION OR PHOTO TO EVALUATE FAILURE MODE REPORTED, WHICH IS ESSENTIAL TO PERFORM A BETTER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA PLUS STOPCOCK WITH 4-WAY 360° TAP ROTATION AND WHITE TAB LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 BD CONNECTA¿¿ PLUS STOPCOCK WITH 4-WAY 360° TAP ROTATION AND WHITE TAB LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860758 BD CONNECTA¿¿ PLUS STOPCOCK WITH 4-WAY 360° TAP ROTATION AND WHITE TAB CONNECTOR FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6060753

    Patients

    Seq Age Sex Outcome Treatment
    1 Other