BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 15549651 · Received October 6, 2022

    Report

    Report Number
    9610825-2022-00396
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Report Date
    February 11, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DYB
    UDI-DI
    04046963318123
    PMA / PMN Number
    K021094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. THE ACTUAL DEFECTIVE DEVICE IS A VALUABLE TOOL IN INVESTIGATING THE CAUSE OF THIS INCIDENT. A REVIEW OF THE BATCH HISTORY RECORDS WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO NON-CONFORMANCES OR DEVIATIONS WERE NOTED DURING THE MANUFACTURING PROCESS OR FINAL INSPECTIONS. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: WE HAVE USED B. BRAUN 4251611-02 CATHETERS FOR A CLINICAL IN USE STUDY AND OBSERVED SOME ISSUES REGARDING SUB-VISIBLE PARTICLES WHILE FLUSHING OUT INJECTIONS WITH THESE CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120897 INTROCAN SAFETY® INTRODUCER, CATHETER DYB B. BRAUN MELSUNGEN AG 4251611-02 21M05G8261 04046963318123

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown