BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE SPINAL TRAY 25 GAUGE WHITACRE NEEDLE

    MDR report key: 20631792 · Received November 6, 2024

    Report

    Report Number
    MW5162304
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    October 28, 2024
    Report Date
    November 4, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP - SPT
    Product Code
    OJH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING SPINAL BLOCK PLACEMENT, SPINAL NEEDLE FRACTURED LEAVING REMNANT IN PATIENT. THIS REQUIRED SURGICAL REMOVAL OF THE RETAINED NEEDLE FRAGMENT. THE NEEDLE WAS A 25 GAUGE WHITACRE NEEDLE FROM A MEDLINE SPINAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539489 MEDLINE SPINAL TRAY 25 GAUGE WHITACRE NEEDLE ORTHOPEDIC TRAY OJH MEDLINE INDUSTRIES LP - SPT DYNJRA1740A 24GMJ821

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention