BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SER PLAS 1ML 13X3,8 U-100 150

    MDR report key: 21832671 · Received April 14, 2025

    Report

    Report Number
    3022699058-2025-00007
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    April 10, 2024
    Report Date
    March 12, 2026
    Manufacturer
    EMBECTA MEDICAL II LLC - PARSIPPANY, NJ
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H11. INVESTIGATION SUMMARY: THE INVESTIGATION IS CURRENTLY IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A DETAILED SUMMARY WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. INVESTIGATION SUMMARY: THE INVESTIGATION IS CURRENTLY IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A DETAILED SUMMARY WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H11. INVESTIGATION SUMMARY: THE INVESTIGATION IS CURRENTLY IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A DETAILED SUMMARY WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H11. INVESTIGATION SUMMARY: THE INVESTIGATION IS CURRENTLY IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A DETAILED SUMMARY WILL BE PROVIDED.

    Description of Event or Problem · 0

    MATERIAL-: 990147. MATERIAL LOT- 4207810. NEEDLE DETACHED FROM THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420336 SER PLAS 1ML 13X3,8 U-100 150 SYRINGE, PISTON FMF EMBECTA MEDICAL II LLC - PARSIPPANY, NJ 990147 4207810

    Patients

    Seq Age Sex Outcome Treatment
    1