BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE PLASTIPAK 1ML INSULIN S/SU

    MDR report key: 21324408 · Received February 6, 2025

    Report

    Report Number
    3022699058-2025-00003
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 9, 2025
    Report Date
    April 16, 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, 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.

    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: N/A. MATERIAL LOT: 4207814. SLIP SYRINGE WITHOUT NEEDLE. THERE ARE FAULTS IN THE PRINTING OF THE SYRINGEGRADUATION (SEVERAL UNITS WHERE THE MARKINGS ARE ERASED AFTER 90 UNITS), BLOCKED SYRINGE PLUNGERS, PIECES OF (WHITE) RUBBER INSIDE THE BARREL. VCOYNE 20JANUARY2025: UPDATES/ADDITIONAL INFORMATION: WE HAVE UPDATE INFORMATION RELATED TO (B)(4). SKU IS 990256, SYRINGE PLASTIPAK 1ML INSULIN S/SU. BATCH: 4207814.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314929 SYRINGE PLASTIPAK 1ML INSULIN S/SU SYRINGE, PISTON FMF EMBECTA MEDICAL II LLC - PARSIPPANY, NJ 990256 4207814

    Patients

    Seq Age Sex Outcome Treatment
    1