BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 7653008 · Received June 29, 2018

    Report

    Report Number
    9610847-2018-00191
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    June 6, 2018
    Report Date
    August 8, 2018
    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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE DEVICE HISTORY REPORT FOR LOT NUMBER 394995 WAS REVIEWED, NO RELATED ABNORMALITIES WERE FOUND. MATERIAL NUMBER 8033736 FOR LOT 394995 WAS MANUFACTURED ON 02/09/2018. THIS IS THE FIRST INSTANCE OF THIS FAILURE MODE WITH THIS LOT NUMBER. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED, WITH NO DEFECTS BEING NOTED DURING FINAL ASSEMBLY OR IN PACKAGING VISUAL INSPECTIONS. ADDITIONALLY SAMPLES AND PHOTOGRAPHS WERE PROVIDED FOR THE PURPOSE OF AIDING OUR QUALITY ENGINEER'S INVESTIGATION, THE AFFECTED SAMPLES SHOWED SIGNS OF RUPTURE IN THE TUBING. THE UNUSED SAMPLE WAS SUBJECTED TO LEAKAGE TESTING AND WAS FOUND TO BE CONFORMING TO PRODUCT STANDARDS. UNFORTUNATELY THE ROOT CAUSE FOR THIS COMPLAINTS COULD NOT BE FINALIZED AT THIS TIME, ALTHOUGH DAMAGE POINTS TO THE DEVICE SUFFERING FROM A HIGH INTERNAL PRESSURE THAT EXCEEDED PRODUCT SPECIFICATIONS. BD APOLOGIZES FOR ANY INCONVENIENCE YOUR FACILITY MAY HAVE EXPERIENCED AS A RESULT OF THIS COMPLAINT AND WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. BASED ON SAMPLE EVALUATION, THE WAY TO DAMAGE THE TUBE (AND BY DEFAULT CAUSE LEAKAGE) IS OMITTING THE IFU RECOMMENDATIONS. QUALITY RECORDS WERE CONSULTED FOR DAMAGED TUBING AND NO ISSUES RELATED HAVE BEEN REPORTED/DETECTED. IT IS IMPORTANT TO MENTION THAT CONNECTA PRODUCT SHOULD BE USED FOR INFUSION THERAPY ONLY. PROCESS FMEA RM5943 WAS REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS. ALWAYS REFER TO IFU FOR PRODUCT USAGE RECOMMENDATIONS. WE WILL KEEP MONITORING THE MANUFACTURING PROCESS AND IN CASE ANY EMERGING TREND IS DETECTED, FURTHER ACTIONS WILL BE TAKEN IF NECESSARY. BASED ON INVESTIGATION RESULTS TO DATE, ROOT CAUSE FOR MANUFACTURING PROCESS CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE A BD CONNECTA¿ STOPCOCK "EXTENSION CRACKED, WITH LEAKAGE OF THE CONTRAST PRODUCT INJECTED." NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE A BD CONNECTA¿ STOPCOCK "EXTENSION CRACKED, WITH LEAKAGE OF THE CONTRAST PRODUCT INJECTED." NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491687 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8033736

    Patients

    Seq Age Sex Outcome Treatment
    1 Other