BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 8699238 · Received June 14, 2019

    Report

    Report Number
    9610825-2019-00215
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 23, 2019
    Report Date
    July 29, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    UDI-DI
    04046963318178
    PMA / PMN Number
    K020785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. ADDITIONAL ATTEMPTS TO RECEIVE THE SAMPLE ARE BEING MADE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: IMMEDIATELY HAD BLOOD COMING OUT OF PUNCTURE SITE. ATTEMPTED TO ASPIRATE BLOOD AND GOT AIR, ABLE TO HOLD DOWN SITE AND FLUSH AND ASPIRATE BLOOD. WITH SECOND FLUSH NOTED NS COMING OUT OF PUNCTURE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493513 INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THE FOZ B. BRAUN MELSUNGEN AG 4252520-02 UNKNOWN 04046963318178

    Patients

    Seq Age Sex Outcome Treatment
    1