BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIKO-FIX

    MDR report key: 4346407 · Received December 18, 2014

    Report

    Report Number
    3007966929-2014-00134
    Event Type
    Injury
    Date Received
    December 18, 2014
    Date of Event
    November 1, 2014
    Report Date
    November 18, 2014
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. ADDITIONAL INFORMATION WAS REQUESTED ON 12/08/2014 AND RECEIVED ON 12/10/2014 CONFIRMING THE PRODUCT MATERIAL MODEL NUMBER AND INFORMING THAT NO ADDITIONAL INFORMATION COULD BE OBTAINED ON ANY OTHER PATIENTS, LOTS AND OR EVENTS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED UNSTERILE NIKO-FIX SECUREMENT (S) WERE USED ON A NUMBER OF IMMUNOSUPPRESSED PATIENTS IN THE HEMATOLOGY/ONCOLOGY WARD THAT DEVELOPED SEPSIS. THE HEALTH CARE PROFESSIONAL COULD NOT PROVIDE AN EXACT NUMBER OF PATIENTS AFFECTED NOR ATTRIBUTE A SPECIFIC LOT NUMBER. THE POTENTIALLY INVOLVED REPORTED LOT NUMBERS THAT WERE PROVIDED ARE: 159427, 159428, 159439, 162484, AND 170512.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830423 NIKO-FIX DEVICE, INTRAVASCULAR CATHETER SECUR KMK UNOMEDICAL LTD. 417118

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening