BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM

    MDR report key: 13347432 · Received January 25, 2022

    Report

    Report Number
    2243072-2022-00065
    Event Type
    Malfunction
    Date Received
    January 25, 2022
    Date of Event
    January 6, 2021
    Report Date
    February 28, 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) MEDICAL (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, (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 DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE REPORTED LOT # 202045 AND LOT # 212048 WERE NOT FOUND FOR THE REPORTED CATALOG # 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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A MV0513-0006 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 212048 OR 202045. THE CUSTOMER HAS CONFIRMED THAT OCCLUSION INITIALLY OCCURRED WHEN DRAWING THE FLUID UP WHICH ALSO RESULTED IN LEAKAGE FROM THE AIR VENT OF THE VIAL ACCESS DEVICE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. A REVIEW OF THE PRODUCTION RECORDS FOR LOTS 212048 AND 202045 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED 4 BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICES, 13 MM HAD ISSUES WITH LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TRICKLES WHEN PUTTING ON AND TAKING OFF TAXOL."

    Description of Event or Problem · 0

    IT WAS REPORTED 4 BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICES, 13 MM HAD ISSUES WITH LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TRICKLES WHEN PUTTING ON AND TAKING OFF TAXOL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178835 BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM SET, IV FLUID TRANSFER LHI BECTON DICKINSON SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown