BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN® SAFETY

    MDR report key: 5492835 · Received March 10, 2016

    Report

    Report Number
    9610825-2016-00083
    Event Type
    Malfunction
    Date Received
    March 10, 2016
    Date of Event
    December 24, 2014
    Report Date
    January 5, 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 · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG 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 · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): WHEN A BLOOD SAMPLE FROM AN (B)(6) PATIENT, DURING WITHDRAWAL OF THE NEEDLE, THE SAFETY CLIP WAS NOT DEPLOYED AND THE PHYSICIAN WAS BITTEN IN THE RIGHT THUMB. DESPITE WEARING STERILE GLOVES, IT BECAME BLOOD UNDER THE GLOVE IN THE THUMB AND PUNCTURE WOUNDS. THE PHYSICIAN HAS BEEN ON TRIPLE THERAPY FOR A PERIOD OF 28 DAYS, WITH MEDICAL AND BIOLOGICAL FOLLOW-UP. DRUG ADDICT PATIENT. THE PERIPHERAL VENOUS NO USABLE. THE DOCTOR HAS "CHOSEN" USE THE FEMORAL ACCESS UNDER ULTRASONOGRAPHY (DEPTH ACCESS: 3 CM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150108 INTROCAN® SAFETY I.V. SAFETY CATHETER DQR B. BRAUN MELSUNGEN AG N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1