BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 11497385 · Received March 16, 2021

    Report

    Report Number
    2243072-2021-00796
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 17, 2021
    Report Date
    May 13, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-03-11. H6: INVESTIGATION SUMMARY: ONE MV0420-0006 FROM LOT 202034 WAS RECEIVED FOR INVESTIGATION. A VISUAL INSPECTION CONFIRMED THE CUSTOMER¿S EXPERIENCE AS AN ADDITIONAL SMARTSITE WAS PRESENT WITHIN THE PACKAGING OF THE PRODUCT. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC. THEY CONFIRMED THAT IN THIS INSTANCE IT IS LIKELY THAT THE SMARTSITE HAD INADVERTENTLY DETACHED FROM ANOTHER PRODUCT AND WAS UNINTENTIONALLY PLACED WITHIN THE PACKAGING ALONGSIDE THE MV0420-0006 PRODUCT; THE ADDITIONAL SMARTSITE WAS THEN NOT IDENTIFIED DURING SUBSEQUENT VISUAL INSPECTIONS DUE TO HUMAN ERROR. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 202034 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SMARTSITE 20MM VENTED VIAL ACCESS DEVICE HAD A BROKEN SPIKE AND FOREIGN MATTER BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "PHARMACY DEPARTMENT OF OUR FACILITY REPORTED AN UNUSED, UNOPENED SPIKE THAT INADVERTENTLY CONTAINS A PIECE OF BROKEN DEVICE (SEE ATTACHED PHOTOGRAPHS). THIS CORRESPONDS TO WHERE THE SPIKE USUALLY BREAKS."

    Additional Manufacturer Narrative · 1

    "UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. 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 EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMARTSITE 20MM VENTED VIAL ACCESS DEVICE HAD A BROKEN SPIKE AND FOREIGN MATTER BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "PHARMACY DEPARTMENT OF OUR FACILITY REPORTED AN UNUSED, UNOPENED SPIKE THAT INADVERTENTLY CONTAINS A PIECE OF BROKEN DEVICE. THIS CORRESPONDS TO WHERE THE SPIKE USUALLY BREAKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394837 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 202034

    Patients

    Seq Age Sex Outcome Treatment
    1