BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ NEEDLE-FREE VALVE

    MDR report key: 12830105 · Received November 17, 2021

    Report

    Report Number
    9616066-2021-52439
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 20, 2021
    Report Date
    November 26, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-12-14. H.6. INVESTIGATION: ONE 2000E7D SAMPLE FROM LOT 1021435 WAS RECEIVED IN SEALED PACKAGING, FOR INVESTIGATION OF COMPLAINT REFERENCE (B)(4) , IN WHICH THE CUSTOMER HAS INDICATED THAT LEAKAGE WAS OBSERVED FROM THE SMARTSITE COMPONENT. FURTHER INFORMATION RELATING TO THE NATURE OF THE REPORTED DEFECT, AND ALSO THE SEQUENCE OF EVENTS PRIOR TO THE DEFECT OCCURRING WERE NOT PROVIDED TO ASSIST THE INVESTIGATION. A VISUAL INSPECTION OF THE SAMPLE CONFIRMED THE CUSTOMER'S REPORT, AS THE FEMALE LUER ADAPTOR (FLA) OF THE SMARTSITE WAS FOUND TO BE SLIGHTLY OVAL IN SHAPE, RATHER THAN CIRCULAR HOWEVER, NO LEAKAGE WAS OBSERVED WHEN THE SMARTSITE WAS SUBJECTED TO PRESSURE TESTING. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1021435 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE OVAL SHAPE IS EXPOSURE OF THE SMARTSITE TO AN EXTERNAL HEAT SOURCE THAT BRINGS THE COMPONENT TEMPERATURE ABOVE 60°C. THE PISTON HEAD OF THE SMARTSITE IS OVAL SHAPED THEREFORE WHEN THE ROUND FLA COMPONENT IS PLACED OVER IT, THE PISTON OPENING IS SQUEEZED SHUT IN ORDER TO CREATE A SEAL. UNDER EXCESSIVE HEAT CONDITIONS, THE FLA MATERIAL CAN SOFTEN, AND AS THE PISTON PUSHES BACK ON THE INSIDE, IT CAN RESHAPE THE FLA TO CONFORM TO THE ORIGINAL OVAL SHAPE OF THE PISTON HEAD. PREVIOUS INVESTIGATIONS HAVE NOT FOUND A POTENTIAL ROOT CAUSE FOR THIS LEVEL OF EXCESS HEAT AS A RESULT OF ANY STAGE OF THE MANUFACTURING OR STERILIZATION PROCESSES AT THE MANUFACTURING SITE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THERE IS NO INCREASED TREND FOR OVAL SMARTSITE VALVES. IT IS POSSIBLE THAT THERE IS A LOCAL ENVIRONMENTAL FACTOR THAT HAS CAUSED THE PRODUCT TO REACH THE ELEVATED TEMPERATURE REQUIRED TO CAUSE THIS ISSUE (E.G. DURING STORAGE OR TRANSIT).

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ NEEDLE-FREE VALVE LEAKED BLOOD FROM THE BLUE PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE OF BLOOD FROM THE BLUE PORT SIDE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ NEEDLE-FREE VALVE LEAKED BLOOD FROM THE BLUE PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE OF BLOOD FROM THE BLUE PORT SIDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728429 BD SMARTSITE¿ NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 1021435

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown