BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMA-LINE BLUE KERR RONG 8IN 3MM BITE

    MDR report key: 5271900 · Received December 7, 2015

    Report

    Report Number
    1423507-2015-00051
    Event Type
    Malfunction
    Date Received
    December 7, 2015
    Date of Event
    September 22, 2015
    Report Date
    December 7, 2015
    Manufacturer
    CAREFUSION
    Product Code
    HAE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 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. DEVICE NOT YET EVALUATED, IF THE DEVICE IS EVALUATED A FOLLOW UP WILL BE SENT.

    Description of Event or Problem · 1

    CUSTOMER STATES VIA EMAIL: HAD ANOTHER KERRISON BREAK. REPORTED ITEM WAS BEING USED ON PATIENT. NO PATIENT HARM REPORTED OR MEDICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION (B)(6) 2015 1. WHAT WAS THE PROCEDURE THAT WAS BEING PERFORMED? LFD 2. DID ANY PART OF THE INSTRUMENT FALL INTO THE PATIENT'S BODY, AND IF SO HOW WAS IT RETRIEVED? NO 3. WAS THERE A MEDICAL PROCEDURE PERFORMED TO VERIFY IF THE INSTRUMENT WAS IN THE PATIENT'S BODY, SUCH AS AN X-RAY? YES 4. WHAT WAS THE PATIENT'S OUTCOME? NORMAL OUTCOME 5. WAS THE PROCEDURE COMPLETED AS PLANNED? YES 6. DO YOU HAVE THE LOT #? NO 7. CAN YOU PLEASE SEND ALL PARTS OF THE INSTRUMENT FOR EVALUATION? YES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802991 CHROMA-LINE BLUE KERR RONG 8IN 3MM BITE RONGEUR, MANUAL HAE CAREFUSION NL4273-83 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1