BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM

    MDR report key: 15135964 · Received July 29, 2022

    Report

    Report Number
    2243072-2022-01027
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    June 28, 2022
    Report Date
    August 11, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    UDI-DI
    10885403228100
    PMA / PMN Number
    K132863
    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 YUKON MEDICAL LLC. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN SECTIONS MANUFACTURER NAME, CITY AND STATE AND MFR SITE AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUTION?: YES. D.10. RETURNED TO MANUFACTURER ON: 02-AUG-2022 H.6. INVESTIGATION SUMMARY: ONE (B)(4)SAMPLE FOR LOT 212048 WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION; THE SAMPLE WAS RECEIVED WITH AN EMPTY MEDICATION VIAL ATTACHED TO THE DEVICE. A VISUAL INSPECTION OF THE VIAL CONFIRMED THE CUSTOMER'S EXPERIENCE WITH THE RUBBER SEPTUM VISIBLY SEPARATED AT THE BASE OF THE VIAL. A CLOSER INSPECTION OF THE SEPTUM APPEARS TO INDICATE THAT THE VIAL HAD BEEN ATTEMPTED TO BE ACCESSED OUTSIDE OF THE TARGET PIERCING AREA OF THE VIAL. 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 SEPTUM BEING PUSHED INTO THE VIAL 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. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE (B)(4)SET IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM THE STOPPER FELL INTO THE VIAL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RUBBER STOPPER WAS PUSHED OUT WHEN THE ADAPTER WAS INSERTED AND FELL INTO THE BOTTLE. THE ADAPTER WAS INSERTED STRAIGHT, IN THE CENTER, AND WITH A SLIGHT TWISTING MOTION INTO THE RUBBER MEMBRANE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM THE STOPPER FELL INTO THE VIAL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RUBBER STOPPER WAS PUSHED OUT WHEN THE ADAPTER WAS INSERTED AND FELL INTO THE BOTTLE. THE ADAPTER WAS INSERTED STRAIGHT, IN THE CENTER, AND WITH A SLIGHT TWISTING MOTION INTO THE RUBBER MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951456 BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM SET, IV FLUID TRANSFER LHI BECTON DICKINSON MV0513 212048 10885403228100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown