BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE

    MDR report key: 15764793 · Received November 9, 2022

    Report

    Report Number
    2243072-2022-01909
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 11, 2022
    Report Date
    December 12, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    20885403228480
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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: 02-NOV-2022. H6. INVESTIGATION SUMMARY: FOUR MV0420-0006 SAMPLES WERE RECEIVED FOR INVESTIGATION IN SEALED PACKAGING; THREE FROM LOT 212064 AND ONE FROM LOT 212085. FROM THE INFORMATION PROVIDED BY THE CUSTOMER IT APPEARS THAT THE CUSTOMER EXPERIENCED DIFFICULTY IN PIERCING THE SEPTUM OF THE VIAL. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. IT WAS NOT POSSIBLE TO CONFIRM THE EXACT ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE IN THIS INSTANCE. THERE WERE NO ISSUES IDENTIFIED DURING TESTING OF THE RETURNED PRODUCT AND IT WAS NOT POSSIBLE TO IDENTIFY ANY MANUFACTURING DEFECTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. A REVIEW OF THE PRODUCTION RECORDS FOR LOTS 212064 AND 212085 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. PLEASE NOTE THAT THE SPIKE OF THE MV0420-0006 VIAL ACCESS DEVICE IS DESIGNED TO BE INSERTED AT THE CENTRAL CIRCLE ON THE RUBBER BUNG OF THE VIAL USING A VERTICAL FORCE AND NOT BY USING AN ANGLED INSERTION TECHNIQUE.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 212064, MEDICAL DEVICE EXPIRATION DATE: 01NOV2024, DEVICE MANUFACTURE DATE: 02NOV2021. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING SMARTSITE¿ VENTED VIAL ACCESS DEVICE THERE WERE CLOGGING ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: THE SPIKE AT THE COUPLING BREAKS, NOT PIERCING THE RUBBER OF CERTAIN DRUGS. THE BAYONET FITTING DOES NOT ALLOW ACCESS TO THE SYRINGE VERY OFTEN, PUTTING THE OPERATOR AT RISK.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING SMARTSITE¿ VENTED VIAL ACCESS DEVICE THERE WERE CLOGGING ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: THE SPIKE AT THE COUPLING BREAKS, NOT PIERCING THE RUBBER OF CERTAIN DRUGS. THE BAYONET FITTING DOES NOT ALLOW ACCESS TO THE SYRINGE VERY OFTEN, PUTTING THE OPERATOR AT RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2949071 BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 212085 20885403228480

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown