BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPROTTE NEEDLE

    MDR report key: 469331 · Received June 24, 2003

    Report

    Report Number
    9611612-2003-00001
    Event Type
    Other
    Date Received
    June 24, 2003
    Date of Event
    April 14, 2003
    Report Date
    June 16, 2003
    Manufacturer
    PAJUNK GMBH
    Product Code
    BSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPRESENTATIVE REPORTED YESTERDAY THAT THE PAJUNK NEEDLE HAD BROKEN OFF INSIDE THE PATIENT'S BACK. THE PATIENT REQUIRED ADDITIONAL SURGERY TO REMOVE THAT PORTION OF THE NEEDLE. NO ADDITIONAL HOSPITALIZATION OR SPECIAL PROCEDURE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPROTTE NEEDLE 24G X 4 3/4" W. INTR. 21GX 1.5" BSP PAJUNK GMBH STANDARD SPROTTE NEEDLE 535

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other