BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 3011164 · Received March 15, 2013

    Report

    Report Number
    3005011024-2013-00001
    Event Type
    Other
    Date Received
    March 15, 2013
    Date of Event
    October 1, 2012
    Report Date
    February 28, 2013
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL REPORTED THAT A NON-STERILE SAMPLE WAS ACCIDENTLY USED IN A RADIOLOGY PROCEDURE. IT WAS LABELED NON-STERILE. DEROYAL: LABELING WAS REVIEWED AND IT WAS CONFIRMED THAT THE PRODUCT WAS MARKED NON-STERILE. THE PAPERWORK WITH THE SAMPLE ALSO STATES "DO NOT USE ON PT, THIS SAMPLE ONLY TO BE USED TO VERIFY COMPONENT ASSEMBLY." THIS OCCURRENCE WAS DETERMINED TO BE AN END USER ERROR.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT A NON-STERILE SAMPLE WAS ACCIDENTALLY USED IN A RADIOLOGY PROCEDURE. IT WAS LABELED NON-STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110872 DEROYAL KDD-KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL INDUSTRIES, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other