BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN SAFETY®

    MDR report key: 8516317 · Received April 15, 2019

    Report

    Report Number
    9610825-2019-00114
    Event Type
    Injury
    Date Received
    April 15, 2019
    Date of Event
    March 20, 2019
    Report Date
    July 3, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    UDI-DI
    04046964398971
    PMA / PMN Number
    K020785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2016018. B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER 400424833. THIS FOLLOW UP REPORT IS BEING FILED TO CORRECT THE BRANDING, PRODUCT CODE, AND 510(K) INFORMATION THAT WAS ENTERED ON THE INITIAL MDR IN THIS REPORT. THIS REPORT WAS FILED FOR ITEM NUMBER, 4253566-01, WHICH IS NOT SOLD IN THE UNITED STATES, HOWEVER A SIMILAR ITEM NUMBER, 4253566-02, IS SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.. THE 510(K) HAS BEEN UPDATED TO REFLECT A 510(K) THAT ITEM 4253566-02 HAS BEEN CLEARED UNDER. NOTE: B. BRAUN IS AWARE THAT THE LISTED EXEMPTION HAS BEEN WITHDRAWN, HOWEVER SINCE THE INITIAL MDR REPORT WAS FILED UNDER THIS EXEMPTION, THE FOLLOW UP IS ALSO BEING FILED UNDER THE EXEMPTION.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018. 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). THE SAMPLES WERE SUBJECTED TO A TEST ON STERILITY AND GROWTH PROMOTION TEST. THE SAMPLES CORRESPOND TO THE TEST FOR STERILITY.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 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) WE RECEIVED 100 INTROCAN SAFETY-W PUR 20G, 1.1X32MM-EU IN ORIGINAL PACKAGE. 20 OF THE RECEIVED SAMPLES WERE FORWARDED TO THE INTERNAL LABORATORY FOR A TEST ON STERILITY. DEVICE HISTORY RECORD REVIEW (DHR): REVIEWED THE DEVICE HISTORY RECORD AND NO ABNORMALITIES FOUND DURING IN PROCESS AND FINAL CONTROL INSPECTION.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE: CATHETER-INFECTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306881 INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THE FOZ B. BRAUN MELSUNGEN AG N/A 18L14G8272 04046964398971

    Patients

    Seq Age Sex Outcome Treatment
    1