BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM

    MDR report key: 14131542 · Received April 16, 2022

    Report

    Report Number
    2243072-2022-00475
    Event Type
    Malfunction
    Date Received
    April 16, 2022
    Date of Event
    March 24, 2022
    Report Date
    June 9, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: AN INVALID LOT # OF 212048 WAS PROVIDED BY THE INITIAL REPORTER. INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES D.9. RETURNED TO MANUFACTURER ON: 20-APR-2022 H.6. INVESTIGATION: ONE MV0513-0006 DEVICE FROM LOT 212048 WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION; ADDITIONALLY, AN EMPTY MEDICATION VIAL WAS RECEIVED. THERE WAS RESIDUAL FLUID IN THE VIAL AND THE DEVICE. A VISUAL INSPECTION CONFIRMED THE CUSTOMER'S DESCRIPTION AS THE SMARTSITE OF THE VIAL ACCESS DEVICE WAS DISCOLOURED WHITE RATHER THAN TRANSPARENT. FUNCTIONAL TESTING WAS PERFORMED WITH A RETAINED 50ML BD PLASTIPAK SYRINGE AND IT WAS OBSERVED THAT THE SMARTSITE PISTON WAS RECESSED INTO THE BODY OF THE SMARTSITE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, AS WELL AS TO THE MANUFACTURING SITE OF THE SMARTSITE COMPONENT FOR INVESTIGATION. THEIR ANALYSIS CONFIRMED THAT THE DISCOLOURATION OF THE SMARTSITE WAS CAUSED BY FLUID WHICH HAD GOTTEN INTO THE HOUSING OF THE SMARTSITE AND HAD DRIED TO CREATE A FILM. THE SMARTSITE WAS THEN DISASSEMBLED AND A CLOSE INSPECTION OF THE COMPONENT PERFORMED; NO DAMAGE OR LEAKAGE WAS OBSERVED TO THE PISTON WHICH MAY HAVE CONTRIBUTED TO THE LEAKAGE. IN THIS INSTANCE IT IS LIKELY THAT THE FILM WITHIN THE SMARTSITE BODY CONTRIBUTED TO THE RECESSED PISTON, AS IT WOULD HAVE INHIBITED THE FREE MOVEMENT OF THE PISTON. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 212048 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. PREVIOUS INVESTIGATIONS HAVE SHOWN THAT IT IS POSSIBLE FOR EITHER INFUSION FLUID OR BLOOD TO ENTER THE CLEAR ENTRAINMENT AREA AROUND THE OUTSIDE OF THE BLUE PISTON DURING NORMAL USE. FLUID CAN ENTER THE ENTRAINMENT AREA DUE TO CAPILLARY ACTION. THIS MEANS THAT DURING CONNECTION THE FLUID IS "PULLED" INTO THE AREA DUE TO THE SMALL GAPS THAT EXIST AROUND THE PERIPHERY OF THE PISTON WHERE IT MEETS THE WHITE CAP AND THE MOTION OF THE PISTON THEN CARRIES THE FLUID DOWNWARD. PREVIOUS STUDIES HAVE ALSO INDICATED THAT FLUID THAT ENTERS THIS AREA CANNOT RE-ENTER THE FLUID PATH DURING NORMAL USE AND CANNOT CAUSE MICROBIAL CONTAMINATION, EVEN AFTER MULTIPLE SMARTSITE® ACTIVATIONS. THE LOWER SEAL BETWEEN THE PISTON (BLUE) AND THE RIGID HOUSING (CLEAR) AND THE SEAL OF THE MALE LUER TIP TO THE ACCESS SURFACE OF THE PISTON OF THE SMARTSITE® VALVE ARE EFFECTIVE IN MAINTAINING A CLOSED SYSTEM. PLEASE NOTE ACCORDING TO THE DIRECTIONS FOR USE OF SMARTSITE STATE "DURING USE OF NEEDLE-FREE VALVE PORT, FLUID MAY BE OBSERVED BETWEEN THE HOUSING AND BLUE PISTON. THIS FLUID DOES NOT ENTER THE FLUID PATH AND REQUIRES NO ACTION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM EXPERIENCED FOREIGN MATTER IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE TAXOL FLUID WAS DRAWN UP, THE SMART SITE STOPPER CHANGED COLOUR FROM BLUE TO WHITE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM EXPERIENCED FOREIGN MATTER IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE TAXOL FLUID WAS DRAWN UP, THE SMART SITE STOPPER CHANGED COLOUR FROM BLUE TO WHITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906062 BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM SET, IV FLUID TRANSFER LHI BECTON DICKINSON 212048

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown