BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 23878188 · Received December 23, 2025

    Report

    Report Number
    9610825-2025-00736
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 10, 2025
    Report Date
    February 16, 2026
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    UDI-DI
    04046963165987
    PMA / PMN Number
    K220626
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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). ONE (1) SAMPLE ATTACHED TO AN EXTENSION SET WAS SUBMITTED TO THE MANUFACTURER FOR EVALUATION. IT WAS NOTED THAT THE BROKEN OFF PIECE OF THE CATHETER WAS NOT RECEIVED. THROUGH VISUAL EXAMINATION, NO DAMAGE ON THE CAPILLARY HUB AND CAPILLARY HORN AREA WERE OBSERVED. NO RESIDUE OF CAPILLARY WAS OBSERVED AT METAL BUSH AFTER DISSECTING THE CAPILLARY HUB THAT ASSUMED THE CAPILLARY HAD COMPLETELY DETACHED FROM THE METAL BUSH. A SIMULATION AT THREE CATHETER ASSEMBLY LINES (CAL) WHICH MANUFACTURE G18 PRODUCTS TO REPLICATE THE REPORTED ISSUE WAS CONDUCTED. THE METAL BUSH AND CAPILLARY INSERTION DEPTH IS MONITORED BY THE IN-LINE VISION SYSTEM, WHICH DETECTS AND AUTOMATICALLY REJECTS ANY INCOMPLETE INSERTIONS. A SIMULATION WAS CONDUCTED USING 30 IN-HOUSE SAMPLES WITH BUSH CAPILLARY DEPTHS GREATER THAN 3.3 MM, WHICH FALL OUTSIDE THE ACCEPTANCE SPECIFICATIONS. THE OBJECTIVE WAS TO INVESTIGATE WHETHER INCOMPLETE INSERTION OF THE METAL BUSH AND CAPILLARY COULD CONTRIBUTE TO CAPILLARY DETACHMENT DEFECTS. THE SIMULATED SAMPLES WERE SENT TO IPQC FOR CATHETER STRENGTH TESTING; THE RESULTS OBTAINED NOTED THAT ALL SAMPLES PASSED THE TEST. BASED ON THE INVESTIGATION, THE REPORTED ISSUE WAS OBSERVED. HOWEVER, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. TRAINING WAS CONDUCTED TO OPERATORS TO HEIGHTEN THEIR AWARENESS OF THIS ISSUE. 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.

    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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: INTROCAN IV CATHETER 4251687-02 FAILED DURING THERAPY. CATHETER BROKE OFF FROM HUB UPON REMOVAL; CATHETER PIECE REMAINS INSIDE PATIENT AND WILL BE EVALUATED BY A VASULAR SURGEON TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2532947 INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ B. BRAUN MELSUNGEN AG 04046963165987

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown