BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 7780742 · Received August 14, 2018

    Report

    Report Number
    9610825-2018-00163
    Event Type
    Malfunction
    Date Received
    August 14, 2018
    Date of Event
    July 19, 2018
    Report Date
    July 2, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    UDI-DI
    04046964381997
    PMA / PMN Number
    K020785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 NO SAMPLE AND NOT PICTURE. BECAUSE OF THIS, FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE. DEVICE HISTORY RECORD (DHR): REVIEWED THE DEVICE HISTORY RECORD AND NO ABNORMALITIES FOUND DURING IN PROCESS AND FINAL CONTROL INSPECTION.

    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 (B)(4). 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 SECTIONS D1, D2, AND G5. THIS REPORT WAS FILED FOR ITEM NUMBER, 4251687-01, WHICH IS NOT SOLD IN THE UNITED STATES, HOWEVER A SIMILAR ITEM NUMBER, 4251687-02, IS SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.. THE 510(K) HAS BEEN UPDATED TO REFLECT A 510(K) THAT ITEM 4251687-02 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 NOTE: B. BRAUN IS AWARE THAT THE LISTED EXEMPTION HAS BEEN WITHDRAWN, HOWEVER SINCE THE INITIAL MDR REPORT WAS FILED UNDER THIS EXEMPTION, THE FOLLOW UP IS ALSO BEING FILED UNDER THE EXEMPTION.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN SPAIN: SAFETY DEVICE OF INTROCAN SAFETY G18 1,3X32 MM-PUR DOESN´T WORK PROPERTELY AND A NURSE HAS A PUNTION IN OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621984 INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THE FOZ B. BRAUN MELSUNGEN AG N/A 18B08G8271 04046964381997

    Patients

    Seq Age Sex Outcome Treatment
    1