BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE INJECTOR

    MDR report key: 3823102 · Received January 20, 2014

    Report

    Report Number
    8010047-2014-00034
    Event Type
    Malfunction
    Date Received
    January 20, 2014
    Date of Event
    November 13, 2013
    Report Date
    November 21, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OMSC HAVE NOT REC'D THE SUBJECT PRODUCTS FOR EVALUATION YET. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. THERE ARE POSSIBILITIES THAT THE INSERTION PORTION OF THE DEVICE WAS DEFORMED AND IT CAUSED THE FAILURE TO EXTEND THE NEEDLE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADD'L AND SIGNIFICANT INFO BECOMES AVAILABLE AT A LATER TIME. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. PLEASE CROSS REFERENCE 8010047-2014-00035.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING UNSPECIFIED PROCEDURE THE NEEDLE DID NOT PROJECT OUT OF THE DISTAL TIP OF THE SHEATH. THE DOCTOR TRIED TO USE ANOTHER ONE, BUT HAD SAME PROBLEM. THERE WAS NO REPORT OF PATIENT INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46644 SINGLE USE INJECTOR INJECTION NEEDLE KNW OLYMPUS MEDICAL SYSTEMS CORPORATION NM-400L-0621 35K

    Patients

    Seq Age Sex Outcome Treatment
    1 PLEASE CROSS REFERENCE 8010047-2014-00034/00035.