BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 11882435 · Received May 26, 2021

    Report

    Report Number
    2243072-2021-01537
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    March 5, 2021
    Report Date
    May 27, 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

    CORRECTION D4: MEDICAL DEVICE LOT #: 202035 H6: INVESTIGATION SUMMARY A MV0420-0006 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 202035. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER APPEARED TO INDICATE THAT THE SMARTSITE WAS THE COMPONENT THAT HAD SEPARATED. 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 202035 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 REPORTED FAULT. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SMARTSITE 20MM VENTED VIAL ACCESS DEVICE SPIKE WAS DEFECTIVE AND BROKE DURING USE, CAUSING TAXOL TO LEAK OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: "THE DEVICE WAS IN THE ANTI-BALLISTIC LABORATORY TO ASPIRATE TAXOLO. DURING THE DISCONNECTION MANEUVER, THE SPIKE HAS SHOWN A STRUCTURAL DEFECT. THE EQUALIZER BROKE OFF CAUSING THE DRUG TO ESCAPE AND LEAK OUT. THE EVENT FORCED THE LOSS OF THE TAXOL BOTTLE. THE SPILL OF THE DRUG SOILED THE WORK SURFACE. THE DEVICE THAT WAS THE SUBJECT OF THE COMPLAINT AND THE DRUG WERE DISPOSED OF."

    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. THE REPORTED LOT # 202035 WAS NOT FOUND FOR THE REPORTED CATALOG # MV0420-0006. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SMARTSITE 20MM VENTED VIAL ACCESS DEVICE SPIKE WAS DEFECTIVE AND BROKE DURING USE, CAUSING TAXOL TO LEAK OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE DEVICE WAS IN THE ANTI-BALLISTIC LABORATORY TO ASPIRATE TAXOLO. DURING THE DISCONNECTION MANEUVER, THE SPIKE HAS SHOWN A STRUCTURAL DEFECT. THE EQUALIZER BROKE OFF CAUSING THE DRUG TO ESCAPE AND LEAK OUT. THE EVENT FORCED THE LOSS OF THE TAXOL BOTTLE. THE SPILL OF THE DRUG SOILED THE WORK SURFACE. THE DEVICE THAT WAS THE SUBJECT OF THE COMPLAINT AND THE DRUG WERE DISPOSED OF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781030 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 202035

    Patients

    Seq Age Sex Outcome Treatment
    1