BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 8160550 · Received December 13, 2018

    Report

    Report Number
    9610825-2018-00265
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    August 16, 2018
    Report Date
    July 2, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    UDI-DI
    04046964398803
    PMA / PMN Number
    K020785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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 400411678. 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 NOTE: B. BRAUN IS AWARE THAT THE LISTED EXEMPTION HAS BEEN WITHDRAWN, HOWEVER SINCE THE INITIAL MDR REPORT WAS FILED UNDER THIS EXEMPTION, THE FOLLOW UP IS ALSO BEING FILED UNDER THE EXEMPTION.

    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). NO SAMPLES RETURNED AND NO PHOTOS PROVIDED FOR THIS NOTIFICATION. FURTHER EVALUATION AND INVESTIGATION CANNOT BE CONCLUDED. THE COMPLAINT IS ONLY TAKEN TO THE KNOWLEDGE AND FILED FOR STATISTICAL PURPOSE. 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 PORTUGAL): CATHETER MIGRATION THROUGH THE VEIN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000416 INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THE FOZ B. BRAUN MELSUNGEN AG N/A 18D13G8362 04046964398803

    Patients

    Seq Age Sex Outcome Treatment
    1