BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 22097266 · Received May 28, 2025

    Report

    Report Number
    9610825-2025-00303
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    April 9, 2025
    Report Date
    July 15, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    UDI-DI
    04046964014055
    PMA / PMN Number
    K111236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    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. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). RECEIVED FIFTY (50) PIECES OF UNUSED INTROCAN SAFETY 3 PUR 18G 1.3X32MM-SA IN ORIGINAL PACKAGING FOR LOT NUMBER 24A02G8372 AND MATERIAL NUMBER 4251131-04. THE RETURNED SAMPLES WERE SUBJECTED TO PACKAGING INTEGRITY TEST, PRODUCT FUNCTIONAL TESTS I.E. PENETRATION FORCE AND GLIDING FORCE AND BACTERIAL ENDOTOXIN TEST. ALL SAMPLES IN ORIGINAL PACKAGING PASSED FOR ALL TESTS. AS NO ABNORMALITY OBSERVED FROM THE RETURNED SAMPLES, COMPLAINT IS NOT CONFIRMED. 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. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION, "PATIENT INTER TO UCI WITH SEPTIC DISRUPTIVE SHOCK, TRI-VALVULAR INSUFFICIENCY, URINARY TRACT INFECTION AND RENAL FAILURE HAVE PHLEBITIS AT THE SITE OF THE PUNCTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397947 INTROCAN SAFETY® CATHETER FOZ B BRAUN MELSUNGEN AG 24A02G8372 04046964014055

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown