BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 3896982 · Received June 4, 2014

    Report

    Report Number
    9610825-2014-00217
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS NOT AVAILABLE FOR EVAL. WITHOUT THE ACTUAL SAMPLE, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSION CAN BE DRAWN. PER THE EVENT DESCRIPTION FROM THE FACILITY, THE REPORTED EVENT OCCURRED WHEN THE NURSE "LAID USED NEEDLE ON BED" AND PLACED NEEDLE IN SHARPS OPENING "WITH NEEDLE END POINTING TOWARDS HER PALM, AND SAFETY CLIP DISLODGED OR MOVED TO THE SIDE". IT SHOULD BE NOTED THAT THE INTROCAN SAFETY IS DESIGNED TO REDUCE THE RISK OF NEEDLE STICK INJURIES. CDC GUIDELINES AND/OR FACILITY PROTOCOLS SHOULD ALWAYS BE FOLLOWED. SHARPS SHOULD BE DISPOSED OF IMMEDIATELY INTO AN APPROPRIATE SHARPS CONTAINER. THE BATCH MFG RECORD WAS REVIEWED AND THERE WERE NO SUCH DEFECT ENCOUNTERED DURING IN-PROCESS INSPECTION AND AT FINAL CONTROL INSPECTION. THE PROCESS CARDS SHOWED NO ABNORMALITIES. A HISTORICAL REVIEW OF THE COMPLAINT DATABASE IDENTIFIED NO ADVERSE TRENDS FOR PRODUCT CODE 4252543-02 OR THE INVOLVED LOT. IF THE SAMPLE AND/OR ADDITIONAL PERTINENT BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327932 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1