BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE INTRODUCER NEEDLE, DIA, 15G 4"

    MDR report key: 3894931 · Received June 25, 2014

    Report

    Report Number
    1526439-2014-11633
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    GAA
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DISCARDED BY CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE DOCTOR WAS REMOVING THE CONFIDENCE INTRODUCER NEEDLE, IT WOULD NOT BUDGE. THE NEEDLE BROKE OFF IN THE PEDICLE, FLUSH WITH THE BONE. THE SHARD OF METAL COULD NOT BE RETRIEVED AND REMAINS IN THE PATIENT. THE REMAINING NEEDLE PORTION WAS DISCARDED AT THE HOSPITAL AND IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370397 CONFIDENCE INTRODUCER NEEDLE, DIA, 15G 4" NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA DEPUY SYNTHES SPINE HPNBD7

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR