BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 9539038 · Received January 2, 2020

    Report

    Report Number
    9610847-2019-00786
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 17, 2019
    Report Date
    February 18, 2020
    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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9193084. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO FURTHER INVESTIGATE THIS ISSUE, ONE PHYSICAL SAMPLE AND PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE SAMPLES WERE EXAMINED AND DAMAGE WAS OBSERVED IN THE UNION OF THE TUBING AND PRODUCT FITTING. OUR QUALITY TEAM WAS UNABLE TO IDENTIFY A MANUFACTURING RELATED DEFECT THAT COULD HAVE RESULTED IN THE OBSERVED TUBING DAMAGE. AT THIS TIME FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR POTENTIAL DEFECTS AND EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA¿ STOPCOCK WAS DAMAGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A COMPLAINT. THE CUSTOMER STATES THAT WHEN CONNECTED AND RUNNING, THE FLUID CAME OUT NEAR FAR LUER CONNECTION. THERE WAS A HOLE IN TUBING AT CANNULA CONNECTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD CONNECTA¿ STOPCOCK WAS DAMAGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A COMPLAINT. THE CUSTOMER STATES THAT WHEN CONNECTED AND RUNNING, THE FLUID CAME OUT NEAR FAR LUER CONNECTION. THERE WAS A HOLE IN TUBING AT CANNULA CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4750 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other