BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPROTTE SPINAL NEEDLE

    MDR report key: 3522819 · Received October 24, 2013

    Report

    Report Number
    1526069-2013-00001
    Event Type
    Injury
    Date Received
    October 24, 2013
    Report Date
    October 21, 2013
    Manufacturer
    PAJUNK GMBH
    Product Code
    BSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE REC'D CALL FROM (B)(6), SURGERY TECH, AT (B)(6) HOSPITAL STATING THAT A SPROTTE SPINAL NEEDLE HAD BROKEN OFF IN A PT'S BACK OVER THE WEEKEND. ALSO SPOKE WITH (B)(6), A WITNESS DURING THE PROCEDURE. THE EVENT WAS REPORTED AS A BREAK IN THE CANNULA DURING INSERTION FOR AN ATTEMPTED EPIDURAL. THE PT WAS IN LABOR AT THE TIME. THE PT WAS DESCRIBED AS "QUITE LARGE", PERHAPS "(B)(6)." PHYSICIAN PERFORMING PROCEDURE AS DR (B)(6). A GENERAL SURGEON WAS REQUIRED TO REMOVE THE NEEDLE; SURGERY WAS PERFORMED TO REMOVE THE NEEDLE, THUS THIS IS A REPORTABLE EVENT. WE ARE INVESTIGATING COMPLAINT REPORTS TO SEE IF THERE IS ANY PATTERN INVOLVING THIS MFR. THE LOT NUMBER INVOLVED IS SOLD OUT SO THERE IS NOTHING TO PUT ON HOLD. THE PT IS REPORTED TO BE DOING OKAY, W/O FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547235 SPROTTE SPINAL NEEDLE 24GAUGE X 6" SPINAL NEEDLE BSP PAJUNK GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention