BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCKS CONNECTA PLUS 3 7 CM WHITE BLEND

    MDR report key: 6899254 · Received September 27, 2017

    Report

    Report Number
    9610847-2017-00087
    Event Type
    Malfunction
    Date Received
    September 27, 2017
    Date of Event
    September 4, 2017
    Report Date
    October 17, 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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: 38 UNUSED SAMPLES AVAILABLE FOR EVALUATION. ALL THE SAMPLES WERE LEAK TESTED AT 43 PSI ACCORDING TO TEST METHOD T400SP FINDING NO LEAKAGE ISSUES. COMPLAINT TRENDING REVIEW OF THIS LOT AND ISSUE REVEALS NO OTHER COMPLAINT. FOR PRODUCT FAMILY THE ISSUE (LEAKAGE) WAS REPORTED BUT UNCONFIRMED LAST TIME ON AUG-2017. DHR/BHR REVIEW: MATERIAL 394945 WITH LOT NUMBER 7152547 WAS MANUFACTURED ON JUN-11-2017 BY EQUIPMENT KA56. NO QN'S OR OTHER EXTRAORDINARY EVENTS HAVE BEEN RELATED TO THE COMPLAINT. 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. INVESTIGATION COMMENTS: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. CUSTOMER REPORTED LEAKAGE ISSUES; HOWEVER SAMPLES HAVE 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 (B)(4) 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. ROOT CAUSE: BASED ON INVESTIGATION RESULTS TO DATE, ROOT CAUSE FOR MANUFACTURING PROCESS CANNOT BE DETERMINED.

    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 A BD CONNECTA¿ STOPCOCKS CONNECTA PLUS 3 7 CM WHITE BLEND LEAKED DURING USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679004 BD CONNECTA¿ STOPCOCKS CONNECTA PLUS 3 7 CM WHITE BLEND STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7152547

    Patients

    Seq Age Sex Outcome Treatment
    1 Other