BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿

    MDR report key: 6961846 · Received October 19, 2017

    Report

    Report Number
    9610847-2017-00121
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Date of Event
    September 28, 2017
    Report Date
    November 7, 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

    ACTUAL SAMPLE WAS RECEIVED. 49 UNUSED AND 2 USED SAMPLES AVAILABLE FOR EVALUATION. ALL THE SAMPLES WERE LEAK TESTED AT 43 PSI ACCORDING TO TEST METHOD T400SP FINDING NO LEAKAGE ISSUES. RETURN SAMPLE SHOWED: PHOTO SHOWED REPORTED DEFECT: YES, NO, N/A. RETURNED MATERIAL SHOWED REPORTED DEFECT: YES NO, N/A. 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. MANUFACTURING REVIEW: NO ISSUES DETECTED FROM MANUFACTURING PROCESS, MAINTENANCE OR CALIBRATED INSTRUMENTS. UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE 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 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. PRODUCT WITHIN SPECIFICATION? YES, NO. BASED ON INVESTIGATION RESULTS TO DATE, ROOT CAUSE FOR MANUFACTURING PROCESS CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: WHEN SAMPLE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL WILL BE FILED. DHR: NO QN'S OR OTHER EXTRAORDINARY EVENTS HAVE BEEN RELATED TO THE COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD CONNECTA¿, IT EXPERIENCED LEAKING. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743111 BD CONNECTA¿ STOP COCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7152547

    Patients

    Seq Age Sex Outcome Treatment
    1 Other