BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 8640736 · Received May 24, 2019

    Report

    Report Number
    9610847-2019-00386
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    May 9, 2019
    Report Date
    September 16, 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
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8213788 & 8339852. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN TEITHER PRODUCTION BATCH. 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 SUBMITTED DEVICES WERE REVIEWED BY OUR QUALITY ENGINEERS; THEY WERE UNABLE TO IDENTIFY ANY DAMAGE TO THE ADAPTER, THE DEVICES WERE ALSO SUCCESSFULLY DISCONNECTED FROM THE LUER CONNECTOR WITHOUT THE APPLICATION OF EXCESS FORCE. UNFORTUNATELY, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA¿ STOPCOCK CLOSURE WAS LOOSE AND CAUSED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOMETIMES, WHEN CONNECTING THE TWO DEVICES, AND AFTER STARTING TO INFUSE, THEY HAVE VERIFIED THAT THE CLOSURE IS NOT HERMETIC (AND EVEN UNSCREWS), RESULTING IN THE LEAKAGE OF FLUID THROUGH THE MALE-FEMALE LUER-LOCK CONNECTION. BOTH DEVICES. THEY HAVE ALSO CHECKED THE PRESENCE OF AIR INSIDE THE TUBE, WHICH THEY ATTRIBUTE TO THIS SAME PROBLEM. THIS HAS BEEN REPORTED INTERNALLY (INTERNAL ATTACHMENTS OF TWO OPERATING ROOM NURSES) ON SEVERAL PREVIOUS OCCASIONS, ALTHOUGH ONLY RECENTLY THEY HAVE BEEN TRANSMITTED TO US AS A FORMAL COMPLAINT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (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 CLOSURE WAS LOOSE AND CAUSED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOMETIMES, WHEN CONNECTING THE TWO DEVICES, AND AFTER STARTING TO INFUSE, THEY HAVE VERIFIED THAT THE CLOSURE IS NOT HERMETIC (AND EVEN UNSCREWS), RESULTING IN THE LEAKAGE OF FLUID THROUGH THE MALE-FEMALE LUER-LOCK CONNECTION. BOTH DEVICES. THEY HAVE ALSO CHECKED THE PRESENCE OF AIR INSIDE THE TUBE, WHICH THEY ATTRIBUTE TO THIS SAME PROBLEM. THIS HAS BEEN REPORTED INTERNALLY (INTERNAL ATTACHMENTS OF TWO OPERATING ROOM NURSES) ON SEVERAL PREVIOUS OCCASIONS, ALTHOUGH ONLY RECENTLY THEY HAVE BEEN TRANSMITTED TO US AS A FORMAL COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432764 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8213788

    Patients

    Seq Age Sex Outcome Treatment
    1 Other