BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 7957743 · Received October 11, 2018

    Report

    Report Number
    9610847-2018-00326
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 19, 2018
    Report Date
    November 1, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY REPORT WAS CONDUCTED FOR LOT NUMBER 8152932. DURING OUR REVIEW, NO ABNORMALITIES RELATED TO THIS EVENT WERE FOUND TO HAVE OCCURRED DURING OUR MONITORING OF THE MANUFACTURING PROCESS. ACCORDING TO OUR RECORDS THIS LOT OF CONNECTA WAS MANUFACTURED 06/18/2018, AND THIS IS THE ONLY INSTANCE OF LEAKAGE DUE TO A LOOSE CAP OCCURRING IN THIS LOT. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED, WITH NO DEFECTS BEING NOTED DURING FINAL ASSEMBLY OR IN PACKAGING VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION, AND THIS EVENT COULD NOT BE EVALUATED WITH THE SUPPLIED PHOTOGRAPH. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CAP FELL OFF THE BD CONNECTA STOPCOCK AND RESULTED IN LEAKAGE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAP FELL OFF THE BD CONNECTA¿ STOPCOCK AND RESULTED IN LEAKAGE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796733 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8152932

    Patients

    Seq Age Sex Outcome Treatment
    1 Other