BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60ML E/T

    MDR report key: 11202808 · Received January 20, 2021

    Report

    Report Number
    3003152976-2021-00043
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    December 28, 2020
    Report Date
    January 29, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    30382903008668
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 1/22/2021. H.6. INVESTIGATION: ONE SEALED SAMPLE OF LOT 1911289 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 MARKING PROCESS, A FAILURE WAS DETECTED RELATED TO AN INCREASED SPEED IN THE CONVEYOR BELT THAT TRANSFERS THE SYRINGES TO THE MARKING MACHINE WHICH RESULTED IN PRODUCT GETTING DAMAGED. 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 A SYRINGE 60ML E/T HAD THE TIP DAMAGED AT AN UNSPECIFIED TIME. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE TIP BENT".

    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 A SYRINGE 60ML E/T HAD THE TIP DAMAGED AT AN UNSPECIFIED TIME. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE TIP BENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97909 SYRINGE 60ML E/T PISTON SYRINGE FMF BECTON DICKINSON, S.A. 300866 1911289 30382903008668

    Patients

    Seq Age Sex Outcome Treatment
    1