BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK WITH EXTENSION TUBING

    MDR report key: 8197775 · Received December 26, 2018

    Report

    Report Number
    9610847-2018-00439
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    December 6, 2018
    Report Date
    February 20, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8212978. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE IN THIS BATCH OF BD CONNECTA. 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. ADDITIONALLY THE SAMPLES SUBMITTED WERE SUBJECTED TO LEAKAGE TESTING; THE RESULTS FROM OUR EXAMINATION DID NOT FIND SIGNS OF LEAKAGE IN ANY OF THE RETURNED UNITS. UNFORTUNATELY WITHOUT THE DUPLICATION OF THE REPORTED FAILURE MODE, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW. BD WAS NOT ABLE TO DUPLICATE AND CONFIRM THE FAILURE BECAUSE THE SAMPLES DON¿T SHOWN THE REPORTED ISSUE, HOWEVER, 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 RM5819 AND EURA EURAP2053001 WERE REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS. 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, THEREFORE, NOGALES SITE OPENED CAPA TO PERFORM AN INVESTIGATION AND DOCUMENTS CORRECTIVE ACTIONS. CAPA 629955 WAS OPENED TO INVESTIGATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED AT THE BD CONNECTA¿ STOPCOCK WITH EXTENSION TUBING INJECTION PORT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED AT THE BD CONNECTA¿ STOPCOCK WITH EXTENSION TUBING INJECTION PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034650 BD CONNECTA¿ STOPCOCK WITH EXTENSION TUBING STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8212978

    Patients

    Seq Age Sex Outcome Treatment
    1 Other