BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 13599955 · Received February 25, 2022

    Report

    Report Number
    9610825-2022-00054
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Report Date
    June 29, 2022
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    UDI-DI
    04046963165925
    PMA / PMN Number
    K020785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIE REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. PLEASE NOTE: THIS REPORT IS BEING RESUBMITTED. THE MFR REPORT NUMBER (9610825-2022-00054) THAT WAS ORIGINALLY SUBMITTED ON 25FEB2022 WAS INCORRECT. THE CORRECT REPORT NUMBER IS 2523676-2022-00257.

    Additional Manufacturer Narrative · 0

    THIE REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT (B)(4). THE EVALUATION IS COMPLETE AND THE FINDING WERE REPORTED UNDER REPORT NUMBER 2523676-2022-00257. PLEASE NOTE: THIS REPORT IS BEING RESUBMITTED. THE MFR REPORT NUMBER (9610825-2022-00054) THAT WAS ORIGINALLY SUBMITTED ON 25FEB2022 WAS INCORRECT. THE CORRECT REPORT NUMBER IS 2523676-2022-00257.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: SAFETY FEATURE ON NEEDLES DOES NOT WORK PROPERLY.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: SAFETY FEATURE ON NEEDLES DOES NOT WORK PROPERLY.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: SAFETY FEATURE ON NEEDLES DOES NOT WORK PROPERLY. PLEASE NOTE: THIS REPORT IS BEING RESUBMITTED. THE MFR REPORT NUMBER (9610825-2022-00054) THAT WAS ORIGINALLY SUBMITTED ON 25FEB2022 WAS INCORRECT. THE CORRECT REPORT NUMBER IS 2523676-2022-00257.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: SAFETY FEATURE ON NEEDLES DOES NOT WORK PROPERLY. PLEASE NOTE: THIS REPORT IS BEING RESUBMITTED. THE MFR REPORT NUMBER (9610825-2022-00054) THAT WAS ORIGINALLY SUBMITTED ON 25FEB2022 WAS INCORRECT. THE CORRECT REPORT NUMBER IS 2523676-2022-00257.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2435135 INTROCAN SAFETY® CATHETER,INTRAVASCULAR FOZ B. BRAUN MELSUNGEN AG 4252535-02 04046963165925

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown