BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 8337365 · Received February 13, 2019

    Report

    Report Number
    9610847-2019-00160
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Date of Event
    January 23, 2019
    Report Date
    March 13, 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
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8180508, 8117528, AND 8152925. OUR RECORDS SHOW THAT THIS IS THE THIRD INSTANCE OF THIS ISSUE OCCURRING LOT 8180508, THE SECOND FOR LOT 8117528, AND THE FIRST FOR LOT 8152925. 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. THE FOLLOWING SAMPLES WERE RECEIVED: 1 USED SAMPLE OF 8117528. 2 UNUSED SAMPLES OF 8152925. 1 USED SAMPLE AND 6 UNUSED OF 8180508. ALL THE SAMPLES WERE LEAK TESTED ACCORDING T423SP WITH 43PSI, THE FOLLOWING ARE THE RESULTS. 1 USED SAMPLE OF BATCH 8180508 LEAKAGE; 1 UNUSED SAMPLE OF BATCH 8180508 LEAKAGE. 1 USED SAMPLE OF 8117528 LEAKAGE. 2 UNUSED SAMPLE OF 8152825 DON¿T SHOWED THE DEFECT, 5 UNUSED SAMPLES OF 8180508 DON¿T SHOWED THE DEFECT. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE 3 OF THE RECEIVED SAMPLES SHOWN LEAKAGE IN 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF 2 OF THE BD CONNECTA¿ STOPCOCK THERE WAS AN ISSUE WITH LEAKAGE FROM ADMINISTRATION CAP.

    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 #: 8180508. MEDICAL DEVICE EXPIRATION DATE: 2021-05-31. DEVICE MANUFACTURE DATE: 2018-08-30. MEDICAL DEVICE LOT #: 8152925. MEDICAL DEVICE EXPIRATION DATE: 2021-05-31. DEVICE MANUFACTURE DATE: 2018-07-27. MEDICAL DEVICE LOT #: 8117528. MEDICAL DEVICE EXPIRATION DATE: 2021-03-31. DEVICE MANUFACTURE DATE: 2021-03-31. (B)(6). 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 2 OF THE BD CONNECTA¿ STOPCOCK THERE WAS AN ISSUE WITH LEAKAGE FROM ADMINISTRATION CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131231 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