BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 8302388 · Received February 4, 2019

    Report

    Report Number
    9610847-2019-00121
    Event Type
    Malfunction
    Date Received
    February 4, 2019
    Date of Event
    January 17, 2019
    Report Date
    January 18, 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
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER REPORTED INJECTION VALVE LEAKAGE; THIS FAILURE MODE WAS DETECTED IN OTHERS CUSTOMER COMPLAINTS WHERE LEAKAGE OCCURRED AT THE VALVE PORT ASSY DUE TO A BAD TUBING ASSEMBLY. ENGINEERING TEAM ASSESSED THE ASSEMBLY PROCESS FINDING A WORN PIN IN STATION 5 THAT COULD CAUSE THE REPORTED FAILURE MODE. THIS PIN IS IN CHARGE OF ASSEMBLING THE GRAY TUBING INTO THE VALVE HOUSING. PROCESS FMEA RM5943 AND PROCESS EURA EURAP2053001 WERE REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8250929. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS 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. UNFORTUNATELY, A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE. INVESTIGATION CONCLUSION: BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE PHOTO OR SAMPLES WERE NOT PROVIDED. ROOT CAUSE DESCRIPTION: BASED ON INVESTIGATION RESULTS TO DATE, FOR LEAKAGE ISSUE (IN INJECTION VALVE) ROOT CAUSE WAS ASSOCIATED TO A BAD TUBING ASSEMBLY BY STATION 5 OF EQUIPMENT VH59. HOWEVER, NOGALES SITE OPENED CAPA TO PERFORM AN INVESTIGATION. RATIONALE: NOGALES WILL OPEN A CAPA (#629955) NOT BECAUSE OF THE CID AS IT IS ¿NO CAPA REQUIRED¿ AS PER CPR-028 BASED ON THE SEVERITY AND OCCURRENCE CALCULATION, THE REASON TO OPEN THE CAPA IS TO BETTER SUPPORT A SITUATION ANALYSIS OPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD CONNECTA¿ STOPCOCK LEAKED FROM THE INJECTION PORT WHEN THE NURSE ATTEMPTED TO ADMINISTER THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94435 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8250929

    Patients

    Seq Age Sex Outcome Treatment
    1 Other