BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE

    MDR report key: 14342332 · Received May 9, 2022

    Report

    Report Number
    2243072-2022-00656
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 13, 2022
    Report Date
    May 16, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. 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

    H6: INVESTIGATION SUMMARY A MV0520-0006 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 9248. FEEDBACK PROVIDED BY THE CUSTOMER INDICATES THAT THE LEAKAGE WAS OBSERVED FROM THE CONNECTION BETWEEN THE VIAL AND THE MV0520-0006 DEVICE DURING ATTEMPTED ASPIRATION. 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 9248 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE MV0520-0006 PRODUCT IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICES EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PREPARATION INVOLVED: CARBOPLATIN. WAS THERE A SPILL? SMALL DROPS ONTO DAYLEE TOWEL. WHAT WAS THE CAUSE OF THE SPILL? IE; WHERE WAS THE EQUIPMENT LEAKING FROM? LEAKING FROM THE BUNG OF THE CVA, NEW CVA JUST RECONSTITUTED, LEAKING WHEN ADJUSTING VOLUME IN 60ML SYRINGE. WAS THERE ANY HARM TO THE OPERATOR? NO HARM, CLEANED UP IMMEDIATELY AND GLOVES CHANGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICES EXPERIENCED LEAKAGE. THE FOLLOWIGN INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PREPARATION INVOLVED: CARBOPLATIN. WAS THERE A SPILL? SMALL DROPS ONTO DAYLEE TOWEL. WHAT WAS THE CAUSE OF THE SPILL? IE; WHERE WAS THE EQUIPMENT LEAKING FROM? - LEAKING FROM THE BUNG OF THE CVA, NEW CVA JUST RECONSTITUTED, LEAKING WHEN ADJUSTING VOLUME IN 60ML SYRINGE. WAS THERE ANY HARM TO THE OPERATOR? - NO HARM, CLEANED UP IMMEDIATELY AND GLOVES CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668295 SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 9248

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown