BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA STOPCOCK

    MDR report key: 9677586 · Received February 6, 2020

    Report

    Report Number
    9610847-2020-00038
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    January 17, 2020
    Report Date
    February 20, 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
    AU
    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 NUMBERS 9220678, 8010919, & 9127844. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT AND ALL QUALITY INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA¿ STOPCOCK HAD A KINK IN THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE RECEIVED ALL 3 BD CONNECTA WITH A KINK AND THEY ARE IN MY OFFICE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9220678. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. DEVICE MANUFACTURE DATE: 2019-09-17. MEDICAL DEVICE LOT #: 8010919. MEDICAL DEVICE EXPIRATION DATE: 2020-12-31. DEVICE MANUFACTURE DATE: 2018-02-15. MEDICAL DEVICE LOT #: 9127844. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2019-06-11. (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¿ STOPCOCK HAD A KINK IN THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE RECEIVED ALL 3 BD CONNECTA WITH A KINK AND THEY ARE IN MY OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142853 BD CONNECTA STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other