BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMA-LINE BLUE KERR RONG 8IN 3MM BITE

    MDR report key: 5140172 · Received October 9, 2015

    Report

    Report Number
    1423507-2015-00046
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Date of Event
    September 15, 2015
    Report Date
    December 14, 2015
    Manufacturer
    CAREFUSION
    Product Code
    HAE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ON 21 SEP 2015 CUSTOMER ADVOCACY SENT THE CUSTOMER AN EMAIL ACKNOWLEDGING RECEIPT OF THE COMPLAINT, PROVIDING THE COMPLAINT NUMBER, AND INQUIRING IF ADDITIONAL INFORMATION MAY BE AVAILABLE. CONFIRMATION WAS ALSO REQUESTED FROM THE CUSTOMER THAT THERE WAS NO PATIENT IMPACT ASSOCIATED WITH REPORTED ISSUE. CUSTOMER ADVOCACY CONTACT INFORMATION WAS PROVIDED. PICTURES OF THE SAMPLE WERE SENT TO THE SUPPLIER AN EVALUATION AND DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN REQUESTED. DEVICE NOT YET EVALUATED, IF A DEVICE IS EVALUATED A FOLLOW-UP WILL BE SENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA EMAIL THAT, "WE HAD A KERRISON BREAK DURING A CASE: #3 KERRISON NL4273-83. REPORTED ITEM WAS BEING USED ON PATIENT. NO PATIENT HARM REPORTED OR MEDICAL INTERVENTION REQUIRED." ON 01 OCT 2015 ADDITIONAL INFORMATION WAS OBTAINED. THE PROCEDURE THAT WAS BEING PERFORMED WAS AN LFD. THE KERRISON DID NOT FALL APART IN THE PATIENT'S BODY AND AN X-RAY WAS USED TO VERIFY. THERE WAS NO PATIENT IMPACT AND THE PROCEDURE WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671517 CHROMA-LINE BLUE KERR RONG 8IN 3MM BITE RONGEUR, MANUAL HAE CAREFUSION NL4273-83 XWDX06

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown