BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 8341389 · Received February 14, 2019

    Report

    Report Number
    9610847-2019-00166
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    January 9, 2019
    Report Date
    March 14, 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: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8184941 & 8121651. OUR RECORDS INDICATE THE EXISTENCE OF A TREND FOR THIS IS IN BATCH 884941 CONNECTA, BUT THIS IS ONLY OCCURRENCE OF THIS ISSUE BEING REPORTED IN 8124651. 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, OUR ENGINEERS WERE UNABLE TO DUPLICATE THIS EVENT THROUGH THE LEAKAGE TESTING OF THE SUBMITTED DEVICES, PREVENTING THEM FORM CONFIRMING THE REPORTED EVENT. HOWEVER BASED ON A SUBSEQUENT REVIEW OF OUR MANUFACTURING LINE , OUR ENGINEERS DETERMINED THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS AN ABNORMALITY IN THE EQUIPMENT RESPONSIBLE FOR TUBING ASSEMBLY. BD WAS NOT ABLE TO DUPLICATE AND CONFIRM THE FAILURE MODE WITH SAMPLES PROVIDED, HOWEVER, CUSTOMER REPORTS ¿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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD CONNECTA¿ STOPCOCK HAD LEAKAGE AT INJECTION PORT.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8184941. MEDICAL DEVICE EXPIRATION DATE: 2021-06-30. DEVICE MANUFACTURE DATE: 2018-08-30. MEDICAL DEVICE LOT #: 8121651. MEDICAL DEVICE EXPIRATION DATE: 2021-04-30. DEVICE MANUFACTURE DATE: 2018-06-20. 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 DURING USE OF THE BD CONNECTA¿ STOPCOCK HAD LEAKAGE AT INJECTION PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135303 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other