BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD 1ML SYRINGE WITH 29GA X 12.7MM NEEDLE

    MDR report key: 3833386 · Received May 14, 2014

    Report

    Report Number
    2243072-2014-00104
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BD
    Product Code
    KZH
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE SAMPLE INVOLVED IS NOT AVAILABLE FOR EVALUATION. THE COUNTRY COORDINATOR IS CHECKING TO SEE IF REPRESENTATIVE UNITS ARE AVAILABLE; HOWEVER, NO SAMPLES HAVE BEEN RECEIVED UP TO THIS POINT. CONCLUSIONS: WITHOUT A SAMPLE, A ROOT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. IF REPRESENTATIVE SAMPLES ARE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT HAD A MORPHINE INJECTION EVERY DAY. ON (B)(6) 2014, THE PE NEEDLE BROKE AND REMAINED IN HIS ABDOMEN. THE PATIENT WENT TO THE HOSPITAL. RADIOGRAPHY CONFIRMED THAT 1CM OF THE NEEDLE WAS INSIDE THE ABDOMEN. SURGERY WAS PERFORMED UNDER LOCAL ANESTHESIA (B)(6) TO REMOVE THE NEEDLE. AFTER THE SURGERY, AN INFLAMMATORY WOUND WITH PUS APPEARED. THE PATIENT MADE A DRESSING EVERY DAY AND CLEANED THE WOUND WITH A SALINE AND BISEPTINE SOLUTION. THE PUS BEGAN TO REABSORB. A FOLLOW-UP APPOINTMENT WITH THE PATIENT'S DOCTOR WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287926 BD 1ML SYRINGE WITH 29GA X 12.7MM NEEDLE SYRINGE WITH NEEDLE KZH BD 3196252

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK