BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60ML E/T

    MDR report key: 10954450 · Received December 5, 2020

    Report

    Report Number
    3003152976-2020-00547
    Event Type
    Malfunction
    Date Received
    December 5, 2020
    Date of Event
    November 10, 2020
    Report Date
    December 9, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    30382903008668
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE UNUSED SAMPLE OF LOT 2003201 WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED AND THE TIP IS OBSERVED TO BE BENT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2003201, FINDING ONE ANNOTATION RELATED TO THE ALLEGED DEFECT. DURING THE ASSEMBLY PROCESS, A FAILURE WAS DETECTED IN THE ASSEMBLY MACHINE THAT RESULTED IN PRODUCT JAMMING WITHIN THE EQUIPMENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 60ML E/T WAS BENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEND STRAIGHT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 60ML E/T WAS BENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEND STRAIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420628 SYRINGE 60ML E/T PISTON SYRINGE FMF BECTON DICKINSON, S.A. 300866 2003201 30382903008668

    Patients

    Seq Age Sex Outcome Treatment
    1