BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA PLUS3 7 CM WHITE BLEND

    MDR report key: 8372085 · Received February 26, 2019

    Report

    Report Number
    9610847-2019-00186
    Event Type
    Malfunction
    Date Received
    February 26, 2019
    Date of Event
    February 6, 2019
    Report Date
    February 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
    EN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8086696. MEDICAL DEVICE EXPIRATION DATE: 2021-02-28. DEVICE MANUFACTURE DATE: 2018-05-09. MEDICAL DEVICE LOT #: 8117528. MEDICAL DEVICE EXPIRATION DATE: 2021-03-31. DEVICE MANUFACTURE DATE: 2018-06-06. MEDICAL DEVICE LOT #: 8149878. MEDICAL DEVICE EXPIRATION DATE: 2021-04-30. DEVICE MANUFACTURE DATE: 2018-07-19. MEDICAL DEVICE LOT #: 8151681. MEDICAL DEVICE EXPIRATION DATE: 2021-04-30. DEVICE MANUFACTURE DATE: 2018-08-08. MEDICAL DEVICE LOT #: 8226712. MEDICAL DEVICE EXPIRATION DATE: 2021-07-31. DEVICE MANUFACTURE DATE: 2018-09-24. INVESTIGATION SUMMARY: BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE IN THE RECEIVED PICTURE. INVESTIGATION CONCLUSION: 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, RM5819 AND PROCESS EURA EURAP2053001 WERE REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS. 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. ALSO NOGALES SITE OPENED CAPA TO PERFORM AN INVESTIGATION. RATIONALE: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTA PLUS3 7 CM WHITE BLEND EXPERIENCED LEAKAGE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165525 CONNECTA PLUS3 7 CM WHITE BLEND STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other