BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAJUNK

    MDR report key: 1573710 · Received January 5, 2010

    Report

    Report Number
    MW5014245
    Event Type
    Injury
    Date Received
    January 5, 2010
    Date of Event
    December 18, 2009
    Report Date
    January 5, 2010
    Manufacturer
    PAJUNK MEDICAL SYSTEM L.P.
    Product Code
    BSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO ADMINISTER SPINAL, THE NEEDLE BROKE OFF WHEN PULLED OUT OF PATIENT. THE TIP OF NEEDLE WAS SURGICALLY REMOVED. DOSE OR AMOUNT: 25G X 3 1/2", ROUTE: SPINAL. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: C-SECTION SPINAL ANESTHETIC. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAJUNK SPROTTE CANNULA W/INTRODUCER BSP PAJUNK MEDICAL SYSTEM L.P. 2013-12 2009-01 803

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention