BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE

    MDR report key: 15130287 · Received July 29, 2022

    Report

    Report Number
    2243072-2022-01018
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    February 22, 2022
    Report Date
    August 11, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    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

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS YUKON. 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. 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: D9: DEVICE AVAILABLE FOR EVALUTION: YES? D9: RETURNED TO MANUFACTURER ON: 02-AUG-2022. H6: INVESTIGATION SUMMARY ONE MV0513-0006 SAMPLE FROM LOT 212048 WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION; THE SAMPLE WAS RECEIVED WITH AN EMPTY MEDICATION VIAL. THE MV0513-0006 PRODUCT WAS DISCONNECTED FROM THE VIAL, AND SUBJECTED TO A FLUSH THROUGH USING A 50ML BD PLASTIPAK SYRINGE; NO OCCLUSION OR FLOW RESTRICTION WAS OBSERVED THROUGHOUT TESTING. THE VIAL WAS THEN REATTACHED TO THE MV0513-0006 DEVICE AND SUBJECTED TO FUNCTIONAL TESTING; AGAIN NO FLOW ISSUES WERE OBSERVED THROUGHOUT TESTING. A VISUAL INSPECTION OF THE SEPTUM OF THE VIAL APPEARS TO INDICATE THAT THE VIAL HAD BEEN ATTEMPTED TO BE ACCESSED OUTSIDE OF THE TARGET PIERCING AREA OF THE VIAL. ADDITIONALLY, THERE WAS FOUND TO BE AN OBSERVABLE DENT IN THE RIM OF THE VIAL INDICATING A POSSIBLE ERROR IN ACCESSING THE MEDICATION VIAL; FURTHERMORE A SLIGHT BEND IN THE SPIKE TIP OF THE VIAL ACCESS DEVICE WAS VISIBLE. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. 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. A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE COULD NOT BE DETERMINED, HOWEVER PREVIOUS INVESTIGATIONS HAVE REPLICATED THIS FAILURE MODE IF THE VIAL SEPTUM IS PIERCED OFF-CENTER OF THE TARGET PIERCING AREA. PLEASE NOTE THAT THE SPIKE OF THE VENTED VIAL ADAPTOR DEVICE IS INTENDED TO BE INSERTED AT THE CENTRAL CIRCLE POSITION OF THE VIAL'S SEPTUM USING A VERTICAL FORCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "FILTER BLOCKED AND MEDICINE DRAWS IT BACK INTO AMPOULE. LIQUID CAN NO LONGER BE DRAWN UP, THE PRESSURE ALWAYS PULLS THE LIQUID BACK FROM THE SYRINGE INTO THE BOTTLE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "FILTER BLOCKED AND MEDICINE DRAWS IT BACK INTO AMPOULE. LIQUID CAN NO LONGER BE DRAWN UP, THE PRESSURE ALWAYS PULLS THE LIQUID BACK FROM THE SYRINGE INTO THE BOTTLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483277 BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 212048

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown