BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 8341249 · Received February 14, 2019

    Report

    Report Number
    9610847-2019-00164
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    January 9, 2019
    Report Date
    April 8, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBERS 8145539, 7123956, 8010910, & 8093759. OUR RECORDS SHOW THAT THERE IS A TREND FOR LEAKAGE IN THIS PRODUCT FAMILY. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THESE LOTS WERE ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, ALTHOUGH OUR ENGINEERS WERE UNABLE TO DUPLICATE THIS EVENT THROUGH THE LEAKAGE TESTING OF THE SUBMITTED DEVICES. HOWEVER, A SUBSEQUENT REVIEW OF OUR MANUFACTURING LINE DETERMINED THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS AN ABNORMALITY IN THE EQUIPMENT RESPONSIBLE FOR TUBING ASSEMBLY. TO PREVENT A REOCCURRENCE OF THIS EVENT WE HAVE RETRAINED OUR PERSONNEL AND OPTIMIZED OUR MANUFACTURING PROCESS TO MONITOR THIS ISSUE MORE THOROUGHLY. BD WAS NOT ABLE TO DUPLICATE AND CONFIRM THE FAILURE MODE WITH THE SAMPLES PROVIDED, HOWEVER, THE CUSTOMER REPORTED ¿PRODUCT / FLUID LEAKING FROM INJECTION PORT¿, AND THIS FAILURE MODE WAS DETECTED IN OTHER 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 RM5819 AND EURA EURAP2053001 WERE REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS. 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 PERFORM BETTER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD CONNECTA¿ STOPCOCK HAD LEAKAGE AT INJECTION PORT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD CONNECTA STOPCOCK HAD LEAKAGE AT INJECTION PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135254 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8145539

    Patients

    Seq Age Sex Outcome Treatment
    1 Other