BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 11803792 · Received May 10, 2021

    Report

    Report Number
    2243072-2021-01383
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 12, 2021
    Report Date
    June 11, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A MV0420-0006 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 202040. FROM THE INFORMATION PROVIDED BY THE CUSTOMER, IT APPEARS THAT THE SMARTSITE SEPARATED FROM THE VIAL ACCESS DEVICE (VAD) WHICH RESULTED IN LEAKAGE OF DRUG. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, HOWEVER IT IS POSSIBLE THAT IT OCCURRED AS A RESULT OF AN INCONSISTENT OR INSUFFICIENT APPLICATION OF GLUE, COUPLED WITH THE TWISTING FORCE DURING ENGAGEMENT OR DISENGAGEMENT OF THE SMARTSITE. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 202040 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SMARTSITE 20MM VENTED VIAL ACCESS DEVICE VALVE AND PERFORATOR BODY DETACHED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: "MULTIPRELIEVE DEVICE FOR FL D. 20MM MV0420-0006 LOT N. 202040 CURRENTLY USED IN OUR GALENIC LABORATORIES PRESENTS A DEFECT RELATED TO DETACHMENT BETWEEN THE BODY OF THE PERFORATOR AND THE SMARTSITE VALVE WITH CONSEQUENT IMPOSSIBILITY OF WITHDRAWING THE DRUG FROM THE BOTTLE: IMMEDIATE REPLACEMENT OF CURRENT STOCKS WITH ANOTHER LOT IS REQUIRED. INVENTORY OF PHARMACY WAREHOUSE: 600 PIECES +230 PIECES IN THE LABORATORIES.".

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: 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. 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 · 1

    IT WAS REPORTED THAT THE SMARTSITE 20MM VENTED VIAL ACCESS DEVICE VALVE AND PERFORATOR BODY DETACHED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "MULTIPRELIEVE DEVICE FOR FL D. 20MM MV0420-0006 LOT N. 202040 CURRENTLY USED IN OUR GALENIC LABORATORIES PRESENTS A DEFECT RELATED TO DETACHMENT BETWEEN THE BODY OF THE PERFORATOR AND THE SMARTSITE VALVE WITH CONSEQUENT IMPOSSIBILITY OF WITHDRAWING THE DRUG FROM THE BOTTLE: IMMEDIATE REPLACEMENT OF CURRENT STOCKS WITH ANOTHER LOT IS REQUIRED. INVENTORY OF PHARMACY WAREHOUSE: (B)(4) IN THE LABORATORIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698267 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 202040

    Patients

    Seq Age Sex Outcome Treatment
    1