BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 13 MM

    MDR report key: 13366160 · Received January 27, 2022

    Report

    Report Number
    2243072-2022-00085
    Event Type
    Malfunction
    Date Received
    January 27, 2022
    Date of Event
    January 6, 2022
    Report Date
    February 23, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    PMA / PMN Number
    K151963
    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: AN MV0413-0006 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 202043 OR 212023. 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 202043 AND 212023 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

    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 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 # MV0413-0006. 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 2 BD SMARTSITE¿ VENTED VIAL ACCESS DEVICES, 13 MM WERE DIFFICULT TO DISCONNECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE TIP DOES NOT COME OUT OF THE RUBBER STOPPER, PULL UP NOT POSSIBLE."

    Description of Event or Problem · 0

    IT WAS REPORTED 2 BD SMARTSITE¿ VENTED VIAL ACCESS DEVICES, 13 MM WERE DIFFICULT TO DISCONNECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE TIP DOES NOT COME OUT OF THE RUBBER STOPPER, PULL UP NOT POSSIBLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84407 BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 13 MM SET, IV FLUID TRANSFER LHI BECTON DICKINSON 212023

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown