BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE 13MM VIAL ACCESS DEVICE

    MDR report key: 20082254 · Received August 27, 2024

    Report

    Report Number
    9616066-2024-01230
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    July 31, 2024
    Report Date
    September 25, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    LHI
    UDI-DI
    07613203011792
    PMA / PMN Number
    K233021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    DURING USE BY END CUSTOMERS, IT WAS REPORTED THAT THE VIAL ADAPTER¿S SPIKE WAS BROKEN OR DAMAGED, THE SYRINGE-VIAL AND ADAPTER SYSTEM HAS A PRESSURE IRREGULARITY, AND THE VIAL WAS LEAKING FROM ANYWHERE EXCEPT DISPENSING POINT. THE FAILURE MODE OF THE DEVICE IS RELATED TO AN UNDETECTED SHORT SHOT CAUSED DURING THE MOLDING OF THE SKIRT AND SPIKE SUBCOMPONENT. THE POSSIBLE ROOT OF THE FAILURE MODE IS RELATED TO INCORRECT MATERIAL FLOW POTENTIALLY CAUSED BY VARIOUS PROCESS FEATURES SUCH AS TIP TEMPERATURE, DIFFERENT CAVITY INJECTION GATE DIAMETERS, CLOGGED TIPS AND MOLD IMBALANCES DUE TO BLOCKED CAVITIES. THESE WERE ALL EVALUATED DURING GEMBA WALKS WITH OPERATIONS AND QUALITY TEAM MEMBER. A QUALITY ALERT WAS CREATED ON SEPTEMBER 02ND, 2024 IN ORDER TO COMMUNICATE TO PRODUCTION AND QUALITY PERSONNEL THAT A COMPLAINT WAS REPORTED BY A CUSTOMER. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED TO THE REPORTED LOTS IN (B)(4) AND NO QNS RELATED TO SHORT SHOT WERE REPORTED. SEE MORE DETAILS BELOW: MODEL 2203E, LOT 23085416, QTY. TOTAL (B)(4) PCS, QNS/ DEVIATIONS. MFG. NONE, DATE AUG 16, 2023. MODEL 2203E, LOT 23105217, QTY. TOTAL (B)(4) PCS, QNS/ DEVIATIONS. MFG. 200344531*, DATE OCT 10, 2023. MODEL 2203E, LOT 23125149, QTY. TOTAL (B)(4) PCS, QNS/ DEVIATIONS. MFG. NONE, DATE DEC 06, 2023. *NOTE ¿ QN (B)(6) WAS REVIEW AND DETERMINED TO BE UNRELATED TO THE SCOPE OF THE FAILURE MODE REPORTED. THE SUBCOMPONENT LOTS OF THE AFFECTED COMPONENTS IN THESE COMPLAINTS WERE BUILT FROM NOVEMBER 2022 TO JANUARY 2023; 19 SUBCOMPONENT BATCHES OF COMPONENTS AFFECTED AND HAD NO QUALITY NOTIFICATIONS FOR THESE SUBCOMPONENT LOTS. BEFORE THE COMPLAINT, IMPROVEMENTS WERE TAKEN AFTER THE REPORTED LOTS WERE BUILT TO ADDRESS A QN ((B)(6)) THAT WAS OBSERVED IN JANUARY 2023 WITH SIMILAR SHORT FAILURE MODE IN THE VIAL ADAPTER COMPONENT. THIS CAUSED A CORRECTION STEP TO CLEAN THE MOLD BUT NO FURTHER ACTION WAS TAKEN. FOR CONTINUOUS IMPROVEMENT AND TO INCREASE RELIABILITY OF THE SUBCOMPONENT MOLDING PROCESS THE FOLLOWING ACTIONS WERE TAKEN: OCTOBER 2023: IMPROVED THE MOLD AND MOLD OUTPUT, EJECTOR PLATE WAS RECTIFIED, AND CORES WERE POLISHED. MARCH 2024: A ROBOT AND EOAT (END OF ARM TOOLING) WAS INSTALLED AND VALIDATED TO IMPROVE THE CELL; PARTS AND RUNNERS ARE NOW COLLECTED BY THE ROBOT TO AVOID PARTS FROM BEING DAMAGED WHEN THE MOLD CLOSES WITH PARTS INSIDE. SINCE THE ABOVE ACTIONS WERE TAKEN THERE HAVE BEEN NO QNS OR CUSTOMER COMPLAINTS RELATED TO SHORT SHOTS. PER BD PROCEDURE, THE COMPLAINT WAS EVALUATED AND IT WAS DETERMINED THAT NO CAPA IS REQUIRED. THE COMPLAINT IS OCCURRING BELOW ACTIONABLE LIMITS. HOWEVER, ADDITIONAL ACTIONS WERE TAKEN TO FURTHER REDUCE RISK ASSOCIATED WITH THE OBSERVED FAILURE MODE: 1. FULL PROCESS DEVELOPMENT INCLUDING STUDIES AND DOE (WATER FLOW, MOLD BALANCE, PRESSURE LOSS, MELT TEMP, RHEOLOGY CURVE, GATE FREEZE, CHECK RING DYNAMIC) WILL BE PERFORMED IN THE MOLD (PROJECT PLAN WAS CREATED AND APPROVED ON MAY 22ND, 2024). IMPLEMENTATION IS EXPECTED TO BE IN MARCH 2025. 2. A MANIFOLD ASSESSMENT AND CLEANING WILL BE PERFORMED UNDER THE PO # (B)(4) WAS APPROVED ON SEPTEMBER 02ND, 2024. IMPLEMENTATION IS TO BE EXPECTED TO BE IN MARCH 2025. 3. TIPS WILL BE ORDERED UNDER THE PO # (B)(4) EMITTED ON SEPTEMBER 02ND, 2024. IMPLEMENTATION IS TO BE EXPECTED TO BE IN MARCH 2025. 4. MOLD REFURBISHMENT WILL BE CARRIED OUT TO ACTIVATE ALL MOLD CAVITIES. THIS WAS APPROVED ON MAY 22ND, 2024. IMPLEMENTATION IS TO BE EXPECTED TO BE IN MARCH 2025. 5. A MAGNETIC TRAMP WAS PURCHASED, INSTALLED, AND IMPLEMENTED IN THE MACHINE MATERIAL HOPPER ON SEPTEMBER 03RD, 2024. 6. A 100% VISUAL INSPECTION WILL BE PERFORMED IN MOLDING AREA APPROVED AND IMPLEMENTED ON SEPTEMBER 03RD, 2024. 7. A 100% VISUAL INSPECTION BASED ON QIS-0049 PRIOR TO BE LOADED INTO THE MULTIVAC TO BE LOOKING FOR ANY MOLDING OR ASSEMBLY DEFECTS WILL BE IMPLEMENTED FOR ALL FUTURE LOTS UNTIL ALL IMPROVEMENTS HAVE BEEN IMPLEMENTED AND VALIDATED ON SEPTEMBER 03RD, 2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SMARTSITE 13MM VIAL ACCESS DEVICE WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT VIAL ADAPTER¿S SPIKE BROKEN OR DAMAGED ¿ DURING USE, SYRINGE-VIAL AND ADAPTER SYSTEM PRESSURE IRREGULARITY, VIAL LEAKING FROM ANYWHERE EXCEPT DISPENSING POINT ¿ DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127184 BD SMARTSITE 13MM VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET LHI SISTEMAS MEDICOS ALARIS S.A. DE C.V. 23105217 07613203011792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown