BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ 3-WAY STOPCOCKS

    MDR report key: 8299143 · Received February 1, 2019

    Report

    Report Number
    9610847-2019-00119
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Date of Event
    January 16, 2019
    Report Date
    February 20, 2019
    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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8212978. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE IN THIS BATCH OF BD CONNECTA. 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. ADDITIONALLY THE SAMPLES SUBMITTED WERE REVIEWED AND FOUND TO BE CLEAR OF ANY OBSERVABLE CRACKS OR DEFORMATIONS THAT COULD LEAD TO A LOOSENED CAP. THE RETURNED UNITS WERE ALSO SUBJECTED TO LEAKAGE TESTING TO IDENTIFY NON-OBSERVABLE DEFECTS; THE RESULTS FROM OUR EXAMINATION FOUND NO SIGNS OF LEAKAGE IN ANY OF THE RETURNED UNITS. UNFORTUNATELY WITHOUT THE DUPLICATION OF THE REPORTED FAILURE MODE, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW. BASED ON INVESTIGATION RESULTS TO DATE, ROOT CAUSE FOR MANUFACTURING PROCESS CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA¿ 3-WAY STOPCOCKS WHITE CAPS ARE LOOSE AND CONNECTA'S ARE EASILY DISCONNECTED. 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¿ 3-WAY STOPCOCKS WHITE CAPS ARE LOOSE AND CONNECTA'S ARE EASILY DISCONNECTED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91323 BD CONNECTA¿ 3-WAY STOPCOCKS STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8226685

    Patients

    Seq Age Sex Outcome Treatment
    1 Other