BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA STOPCOCK

    MDR report key: 10222463 · Received July 2, 2020

    Report

    Report Number
    9610847-2020-00196
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Date of Event
    June 10, 2020
    Report Date
    July 31, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES. D.10 RETURNED TO MANUFACTURER ON: 2020-07-16. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9122561 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, ONE VIDEO SAMPLE AND ONE PHYSICAL USED SAMPLE WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE RETURNED SAMPLE, DAMAGE WAS OBSERVED AT THE UNION OF THE TUBING AND HOUSING COMPONENT. IT IS POSSIBLE THAT THE OBSERVED DAMAGE RESULTED FROM AN INCORRECT ASSEMBLY OF THE TWO COMPONENTS WITHIN THE MANUFACTURING FACILITY. A QUALITY ALERT HAS BEEN COMMUNICATED TO ALL APPLICABLE MANUFACTURING PERSONNEL TO RAISE AWARENESS OF THIS POTENTIAL DEFECT. BASED ON INVESTIGATION RESULTS TO DATE, A PROBABLE ROOT CAUSE SHOULD BE AN INCORRECT ASSEMBLY OF TUBE TO HOUSING BY SOME MISALIGNMENT ON STATION 7. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR ANY POSSIBLE DEFECTS OR EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONNECTA¿ STOPCOCK EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE FROM EXT. SET OF CONNECTA.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD CONNECTA¿ STOPCOCK EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE FROM EXT. SET OF CONNECTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686426 BD CONNECTA STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9122561

    Patients

    Seq Age Sex Outcome Treatment
    1 Other