BEUDAMED
    FDA Adverse Event Injury Summary report: N

    27 G X 3 1/2 IN. BD¿ WHITACRE HIGH FLOW, PENCIL POINT NEEDLE

    MDR report key: 5214132 · Received November 10, 2015

    Report

    Report Number
    2618282-2015-00002
    Event Type
    Injury
    Date Received
    November 10, 2015
    Date of Event
    September 14, 2015
    Report Date
    October 20, 2015
    Manufacturer
    BD CARIBE LTD.
    Product Code
    BSP
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS NOTIFIED FROM THE FDA, REF MW5056448. NO CUSTOMER CONTACT INFORMATION WAS INCLUDED. STATE DELIVERING THE INCIDENT INFORMATION ((B)(6)) IS USED AS THE INITIAL REPORTER STATE IS UNKNOWN. RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5062666. CONCLUSIONS - AS THERE WAS NO ACTUAL RETURNED SAMPLE FOR EVALUATION, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. A SAMPLE IS NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE FACILITY IN LABOR AND WAS ADMITTED FOR URGENT REPEAT CESAREAN SECTIONS. DURING INSERTION OF THE SPINAL ANESTHETIC, A PORTION OF THE DEVICE'S NEEDLE BROKE OFF IN THE L1-2 INTERSPINOUS REGION. A SECOND SPINAL NEEDLE WAS INSERTED AND THE C-SECTION WAS COMPLETED WITHOUT ISSUE. NEUROSURGERY WAS CONSULTED AND THE RETAINED NEEDLE WAS SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744014 27 G X 3 1/2 IN. BD¿ WHITACRE HIGH FLOW, PENCIL POINT NEEDLE ANESTHESIA SPINAL NEEDLE BSP BD CARIBE LTD. 5062666

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention