BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE SPINAL PACK

    MDR report key: 23829919 · Received December 17, 2025

    Report

    Report Number
    MW5180701
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    December 9, 2025
    Report Date
    December 10, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - SPT
    Product Code
    OFT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN PLACING A SPINAL USING THE MEDLINE PACK, THE STYLET FROM THE SPINAL NEEDLE GETS STUCK WHEN PULLING IT OUT. THIS HAS HAPPENED ON SEVERAL PACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386656 MEDLINE SPINAL PACK SPINAL EPIDURAL ANESTHESIA KIT OFT MEDLINE INDUSTRIES, LP - SPT 25FBH209

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown