BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 20 MM

    MDR report key: 15130232 · Received July 29, 2022

    Report

    Report Number
    2243072-2022-01019
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    June 28, 2022
    Report Date
    August 24, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS YUKON MEDICAL LLC. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INITIAL REPORTER FACILITY NAME: (B)(6). 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 02-AUG-2022. H6: INVESTIGATION SUMMARY ONE MV0420-0006 SAMPLE FROM LOT 212049 WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION. THE SAMPLE HAD RESIDUAL FLUID IN THE DEVICE AND WAS RECEIVED ATTACHED TO A MEDICATION VIAL. FUNCTIONAL TESTING WAS PERFORMED BY FLUSHING FLUID THROUGH THE MV0420-0006 DEVICE USING A RETAINED 50ML BD PLASTIPAK SYRINGE; LEAKAGE WAS OBSERVED FROM BASE OF THE SMARTSITE CONFIRMING THE CUSTOMER'S EXPERIENCE. DURING MANUAL MANIPULATION IT WAS NOTED THAT THE SMARTSITE REMAINED SECURELY CONNECTED TO THE BODY OF THE VIAL ACCESS DEVICE (VAD), AND NO ADDITIONAL DAMAGE WAS NOTED. 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 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 212049 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 20 MM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: THE ADAPTER TRICKLED IN THE SMART SITE. IT WAS DRIPPING OUT FROM UNDERNEATH THE SMART SITE. WHEN THE CYTOSTATICS WERE TURNED OVER AND THE CYTOSTATIC DID NOT DRIP, BUT IT DREW AIR INTO THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 20 MM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: THE ADAPTER TRICKLED IN THE SMART SITE. IT WAS DRIPPING OUT FROM UNDERNEATH THE SMART SITE. WHEN THE CYTOSTATICS WERE TURNED OVER AND THE CYTOSTATIC DID NOT DRIP, BUT IT DREW AIR INTO THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316237 BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 20 MM SET, IV FLUID TRANSFER LHI BECTON DICKINSON 212049

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown