BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREBLOCK SPINAL ANESTHESIA KIT

    MDR report key: 19184332 · Received April 24, 2024

    Report

    Report Number
    MW5154303
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    April 10, 2024
    Report Date
    April 22, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC, SUBSIDIARY TELEFLEX INC
    Product Code
    BSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN SPINAL NEEDLE REMOVED (C-SECTION PREP), APPROXIMATELY 4-5 CM OF NEEDLE MISSING, BROKEN OFF IN PATIENT. REQUIRED NEW SPINAL. REMOVAL DONE OF THE RFB (NEEDLE) AFTER DELIVERY OF THE BABY. SEPARATE PROCEDURE. NEEDLE: SPROTTE SPINAL NEEDLE: 25 GA X 3-1/2 (90MM) WITH 21 GA X 30MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879240 SUREBLOCK SPINAL ANESTHESIA KIT NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP ARROW INTERNATIONAL LLC, SUBSIDIARY TELEFLEX INC ASA-25090-SB 33F23H0235

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Required Intervention