BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8670727 · Received June 5, 2019

    Report

    Report Number
    3003152976-2019-00382
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Date of Event
    May 21, 2019
    Report Date
    July 17, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE AND TWO PHOTO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. VISUAL INSPECTION OF THE PHOTOS AND SAMPLE REVEALED DAMAGE ON THE BARREL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1902256, FINDING ONE ANNOTATION RELATED TO THE ALLEGED DEFECT. DURING THE ASSEMBLY PROCESS, A MALFUNCTION WAS DETECTED IN THE BARREL FEEDING STATION THAT RESULTED IN DAMAGE TO THE BARREL. THE MECHANICAL TEAM REPAIRED THE FAILURE AND IMPACTED UNITS WERE SCRAPPED. IT WAS DETERMINED THE ISSUE REPORTED IS RELATED TO THIS MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UPPER BODY OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WAS FOUND DEFORMED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "UPPER BODY OF THE SYRINGE IS DEFORMED (LOT 1902256 EXPIRY 01/2024)."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (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 · 1

    IT WAS REPORTED THAT THE UPPER BODY OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WAS FOUND DEFORMED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "UPPER BODY OF THE SYRINGE IS DEFORMED (LOT 1902256 EXPIRY 01/2024)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464482 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1902256

    Patients

    Seq Age Sex Outcome Treatment
    1 Other