BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML LUER-LOK SYRINGE

    MDR report key: 8695884 · Received June 13, 2019

    Report

    Report Number
    3003152976-2019-00396
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 20, 2019
    Report Date
    July 8, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE UNUSED SAMPLE WAS RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION, DAMAGE WAS OBSERVED ON THE BARREL THREAD. A DEVICE HISTORY REVIEW FOR LOT 1902235 DID NOT REVEAL ANY ANNOTATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS RELATED TO THIS ISSUE. PRODUCT IS INSPECTED THROUGHOUT MANUFACTURING ACCORDING TO PROCEDURE, ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT ACCORDINGLY. WHILE WE COULD NOT IDENTIFY ANY DIRECT ISSUES, IT WAS DETERMINED THE DAMAGE LIKELY OCCURRED DURING TRANSPORT FROM THE INJECTION MACHINE TO THE ASSEMBLY FEEDER. CHANGES HAVE BEEN RECENTLY IMPLEMENTED TO REDUCE OVER-FEEDING BARRELS ENTERING THE MACHINE AND PROTECTION IN THE TRANSPORTS HAVE BEEN UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE THE SCREW THREAD OF THE SYRINGE WAS DAMAGED AND THEREFORE UNUSABLE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: IT WAS FOUND THAT THE SCREW THREAD OF THE SYRINGE WAS DAMAGED AND THEREFORE UNUSABLE IN THE STATE. THIS OBSERVATION WAS OBSERVED BEFORE USE OF THE SYRINGE.

    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 BEFORE USE OF THE BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE THE SCREW THREAD OF THE SYRINGE WAS DAMAGED AND THEREFORE UNUSABLE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: IT WAS FOUND THAT THE SCREW THREAD OF THE SYRINGE WAS DAMAGED AND THEREFORE UNUSABLE IN THE STATE. THIS OBSERVATION WAS OBSERVED BEFORE USE OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490110 BD PLASTIPAK 50ML LUER-LOK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1902235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other