BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE

    MDR report key: 13346742 · Received January 25, 2022

    Report

    Report Number
    2243072-2022-00063
    Event Type
    Malfunction
    Date Received
    January 25, 2022
    Date of Event
    January 6, 2022
    Report Date
    February 23, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    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

    H.6. INVESTIGATION: THE MV0513-0006 PRODUCTS WERE NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLES WERE FROM LOTS 202045 AND 212048. A PHOTOGRAPH PROVIDED BY THE CUSTOMER INDICATES THAT THE VIAL SEPTUM HAS BEEN PUSHED INTO THE VIAL WHILE ATTACHED TO THE MV0513-0006 PRODUCT. A REVIEW OF THE PRODUCTION RECORDS FROM 202045 AND 212048 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    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. DATE OF EVENT: UNKNOWN. THE REPORTED LOT NUMBERS 202045 AND 212048 WERE NOT FOUND FOR THE REPORTED CATALOG NUMBER MV0513-0006. 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 · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE HAD ISSUES WITH THE WHOLE STOPPER FALLING INTO THE TAXOL BOTTLE WHEN PIERCING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "WHEN PIERCING THE TAXOL BOTTLE, THE RUBBER STOPPER FALLS INTO THE BOTTLE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE HAD ISSUES WITH THE WHOLE STOPPER FALLING INTO THE TAXOL BOTTLE WHEN PIERCING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "WHEN PIERCING THE TAXOL BOTTLE, THE RUBBER STOPPER FALLS INTO THE BOTTLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746327 BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown