BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 11441158 · Received March 8, 2021

    Report

    Report Number
    2243072-2021-00718
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Date of Event
    February 9, 2021
    Report Date
    May 21, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    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: 2021-03-09. H6: INVESTIGATION SUMMARY: ONE MV0420-0006 SAMPLE FROM LOT 202035 WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION. THE DEVICE WAS RECEIVED ATTACHED TO A 50ML GEMCITABINE VIAL WITH RESIDUAL MEDICATION. FURTHER INFORMATION PROVIDED BY THE CUSTOMER INDICATES THAT THE SEPARATION OCCURRED DURING PREPARATION OF THE DRUG. A VISUAL INSPECTION CONFIRMED THE CUSTOMER¿S EXPERIENCE AS THE SMARTSITE WAS RECEIVED DETACHED FROM THE VIAL ACCESS DEVICE. A CLOSER EXAMINATION OF THE NECK OF THE MV0420-0006 SAMPLE AND THE DETACHED SMARTSITE IDENTIFIED RESIDUAL SOLVENT AT THE AFFECTED COMPONENTS. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. A DEFINITIVE ROOT CAUSE FOR OBSERVED SEPARATION COULD NOT BE DETERMINED, 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 202035 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. ALTHOUGH IT WAS NOT POSSIBLE TO DETERMINE A DEFINITE ROOT CAUSE FOR THIS ISSUE, THE QUALITY TEAM AT THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS COMPLAINT IN ORDER TO BE AWARE OF THE REPORTED FAILURE MODE DURING FUTURE PRODUCTION OF THIS PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SMARTSITE 20MM VENTED VIAL ACCESS DEVICE EXPERIENCED SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN SAMPLING GEMCITABINE WITH 60ML SYRINGE ON SPIKE, UPON REMOVAL OF THE SYRINGE THE SYRINGE INSERTION PORT DISENGAGED FROM THE SPIKE AND REMAINS ON THE SYRINGE.

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS YUKON. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). MEDICAL DEVICE LOT #: AN INVALID LOT # OF 202035 WAS PROVIDED BY THE INITIAL REPORTER 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 EXPERIENCED SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN SAMPLING GEMCITABINE WITH 60ML SYRINGE ON SPIKE, UPON REMOVAL OF THE SYRINGE THE SYRINGE INSERTION PORT DISENGAGED FROM THE SPIKE AND REMAINS ON THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338275 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE VIAL ACCESS DEVICE LHI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1