BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCKS CONNECTA PLUS 3 7 CM WHITE BLEND

    MDR report key: 6984107 · Received October 27, 2017

    Report

    Report Number
    9610847-2017-00131
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    October 3, 2017
    Report Date
    November 28, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    K974083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: ONE SAMPLE AVAILABLE FOR EVALUATION. SAMPLE WAS LEAK TESTED AT 43 PSI ACCORDING TO TEST METHOD T400SP FINDING NO LEAKAGE ISSUES. NO SAMPLE RETENTION FOR STOPCOCKS PRODUCT. COMPLAINT TRENDING REVIEW OF THIS LOT AND ISSUE REVEALS NO OTHER COMPLAINT. FOR PRODUCT FAMILY THE ISSUE (LEAKAGE) WAS REPORTE D BUT UNCONFIRMED ON NOV-17. MATERIAL 394945 WITH LOT NUMBER 7152548 WAS MANUFACTURED ON JUN-29-2017 BY EQUIPMENT KA56. NO QN'S OR OTHER EXTRAORDINARY EVENTS THAT CAN EXPLAIN THE INCIDENT HAVE BEEN RELATED. NO ISSUES DETECTED FROM MANUFACTURING PROCESS, MAINTENANCE OR CALIBRATED INSTRUMENTS. ISSUE PREVIOUSLY REPORTED BUT UNCONFIRMED FOR ASSOCIATED STOPCOCKS PRODUCT FAMILY. THE COMPLAINT RATE REMAINS AT HISTORICAL LEVELS AS OBSERVED ON RECORDS. NO TRENDING OBSERVED BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. CUSTOMER REPORTED LEAKAGE ISSUES; HOWEVER SAMPLE HAS BEEN LEAK TESTED SHOWING NO PROBLEM. QUALITY RECORDS HAVE BEEN CONSULTED FOR TRACKING AND TRENDING PURPOSES AND NO ISSUES LIKE THIS ARE DETECTED WHICH MEANS PRETTY LOW OCCURRENCE. 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.

    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 SALINE LEAKED FROM A BD CONNECTA¿ STOPCOCKS CONNECTA PLUS 3 7 CM WHITE BLEND. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764597 BD CONNECTA¿ STOPCOCKS CONNECTA PLUS 3 7 CM WHITE BLEND STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7152548

    Patients

    Seq Age Sex Outcome Treatment
    1 Other