BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN® SAFETY

    MDR report key: 5110901 · Received September 29, 2015

    Report

    Report Number
    9610825-2015-00424
    Event Type
    Injury
    Date Received
    September 29, 2015
    Report Date
    September 7, 2015
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DQR
    PMA / PMN Number
    K982805
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4). THIS REPORT HAS BEEN IDENTIFIED AS (B)(4) INTERNAL REPORT # (B)(4). NO SAMPLE HAS BEEN RETURNED FOR INVESTIGATION. THE BATCH RECORD COULD NOT BE REVIEWED SINCE THE LOT NUMBER IS NOT KNOWN. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A THOROUGH INVESTIGATION CAN NOT BE PERFORMED. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE ACTUAL MANUFACTURER. IF THE SAMPLE OR LOT NUMBER AND/OR ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6)): THE NURSE HAS PLACED THE CATHETER ON THE TABLE (SECURITY SYSTEM SET). WHEN PICKING UP THE KT TO THROW IN A MEDICAL WASTE CONTAINER, THE NURSE WAS PRICKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641731 INTROCAN® SAFETY I.V. SAFETY CATHETER DQR B. BRAUN MELSUNGEN AG N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1