BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 13 MM

    MDR report key: 13358234 · Received January 26, 2022

    Report

    Report Number
    2243072-2022-00071
    Event Type
    Malfunction
    Date Received
    January 26, 2022
    Date of Event
    January 6, 2022
    Report Date
    February 23, 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 (B)(4). THIS SITE IS AN (B)(4) MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4)REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 212023, MEDICAL DEVICE EXPIRATION DATE: 05/27/2024, DEVICE MANUFACTURE DATE: 11/21/2021. THE REPORTED LOT # 202043 WAS NOT FOUND FOR THE REPORTED CATALOG #-0006. 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

    INVESTIGATION: A MV0413-0006 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLES WERE FROM LOTS 212023 AND 202043. THE CUSTOMER REPORTED THAT IT WAS NOT POSSIBLE TO DRAW UP FLUID WITH THE DEVICE WHEN ACCESSING A VIAL. THE CUSTOMER PROVIDED A PHOTOGRAPH OF THE AFFECTED DEVICE; ANALYSIS OF THE PHOTOGRAPH CONFIRMED THE CUSTOMER'S EXPERIENCE WITH THE SPIKE NOTED TO NOT HAVE FULLY PENETRATED THE RUBBER SEPTUM OF THE VIAL. A REVIEW OF THE PRODUCTION RECORDS FROM LOTS 212023 AND 202043 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.

    Description of Event or Problem · 0

    IT WAS REPORTED 4 BD SMARTSITE¿ VENTED VIAL ACCESS DEVICES, 13 MM HAD ISSUES WITH NEEDLE SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ADAPTER CAN NOT BE PIERCED INTO BOTTLE. THE TIP DOES NOT COME OUT OF THE RUBBER STOPPER OR ONLY VERY LITTLE, WIND UP SO NOT POSSIBLE."

    Description of Event or Problem · 0

    IT WAS REPORTED 4 BD SMARTSITE¿ VENTED VIAL ACCESS DEVICES, 13 MM HAD ISSUES WITH NEEDLE SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ADAPTER CAN NOT BE PIERCED INTO BOTTLE. THE TIP DOES NOT COME OUT OF THE RUBBER STOPPER OR ONLY VERY LITTLE, WIND UP SO NOT POSSIBLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178468 BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 13 MM SET, IV FLUID TRANSFER LHI BECTON DICKINSON 202043

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown