BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE 13MM CLOSED VIAL ACCESS DEVICE

    MDR report key: 13347416 · Received January 25, 2022

    Report

    Report Number
    2243072-2022-00066
    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

    INVESTIGATION: A MV0513-0006 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 202045 OR 212048. THE CUSTOMER PROVIDED PHOTOGRAPHS OF THE REPORTED ISSUE; ANALYSIS OF THE PHOTOGRAPHS CONFIRMED THE CUSTOMER'S EXPERIENCE WITH THE VIAL SEPTUM NOTED TO BE PUSHED INTO THE BOTTOM OF THE VIAL. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 202045 OR 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 MANUFACTURE: 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. THERE WERE MULTIPLE LOT NUMBERS WHICH MAY HAVE BEEN INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 202045 (INVALID LOT #), MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: NA. MEDICAL DEVICE LOT #: 212048 (INVALID LOT #), MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: NA. INITIAL 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD SMARTSITE 13MM CLOSED VIAL ACCESS DEVICES EXPERIENCED THE RUBBER STOPPER DISLODGING INTO THE VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PIERCING, RUBBER STOPPER DETACHES FROM ALUMINUM CAP AND FALLS INTO BOTTLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD SMARTSITE 13MM CLOSED VIAL ACCESS DEVICES EXPERIENCED THE RUBBER STOPPER DISLODGING INTO THE VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PIERCING, RUBBER STOPPER DETACHES FROM ALUMINUM CAP AND FALLS INTO BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034341 BD SMARTSITE 13MM CLOSED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown