BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 23199778 · Received October 2, 2025

    Report

    Report Number
    9610825-2025-00575
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    August 26, 2025
    Report Date
    October 22, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 REPORTED 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. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4). PREMARKET SUBMISSION # K020785.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). COMPLAINT ANALYSIS: THE SITUATION DESCRIBED DURING A SURGERY, THE IV SOFT CATHETER BROKE IN PATIENT BODY DURING THE A LINE PUNCTURE. SO, PHYSICIAN REMOVED THAT BROKEN SOFT CATHETER FROM THAT PATIENT, AND PROCEEDED PLANNED SURGERY THEN. KNOWN THAT THE PATIENT HAS BEEN DISCHARGED NOW. DEVICE HISTORY RECORD (DHR): REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 25A26G8262 AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. SAMPLE FOR EVALUATION: RECEIVED 1 PIECE OF USED INTROCAN SAFETY PUR 20G, 1.1X32MM-AP CAPILLARY HUB AND THE TEAR OFF PART OF THE CAPILLARY AND A PIECE OF PRIMARY PACKAGING PAPER WITH BATCH NUMBER 25A26G8262 AND ARTICLE NUMBER 4251644-03. THE PROTECTIVE CAP AND CANNULA HUB WERE NOT RETURNED FOR INVESTIGATION. VISUAL INSPECTION: OBSERVED DAMAGED/A TEAR AT THE CAPILLARY TIP AND THE TEAR OFF CAPILLARY AREA EXHIBITS A V-SHAPE CUT. REVIEWED ASSEMBLY PROCESS: BASED ON INVESTIGATION AND SIMULATION, TEAR OFF CAPILLARY DEFECT IS NOT ATTRIBUTED TO MANUFACTURING PROCESS FAILURE SINCE SUCH DEFECT WILL BE ABLE TO BE DETECTED AND REJECTED BY THE IN-LINE VISION SYSTEM. DAMAGE INDUCED AFTER THE ASSEMBLY PROCESS IS NOT POSSIBLE SINCE THE CATHETER HAS BEEN PROTECTED WITH A PROTECTIVE CAP. CONCLUSION: THE TEAR OFF CAPILLARY AREA EXHIBITS V-SHAPE CUT SHAPE AND DISTORTION AS A RESULT OF BEING CUT BY THE CANNULA BEVEL. THE SAMPLE HAS ALSO EVIDENCE OF USAGE. HENCE, THE TEAR OFF WAS NOT CAUSED BY THE MANUFACTURING PROCESS OR ELSE IT WILL BE VISUALLY DETECTABLE BY THE USER BEFORE USE. THIS DEFECT WAS CONCLUDED AS DEFECT DUE TO WRONG HANDLING. COMPLAINT IS CONFIRMED. NOTE: THIS REPORTED 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: "DURING THE SURGERY, THE IC SOFT CATHETER BROKE IN PATIENT BODY DURING THE A LINE PUNCTURE. PHYSICIAN REMOVED THAT BROKEN SOFT CATHETER FROM THAT PATIENT, AND PROCEEDED PLANNED SURGERY. IT IS KNOWN THAT THE PATIENT HAS BEEN DISCHARGED NOW.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277412 INTROCAN SAFETY® CATHETER,INTRAVASCULAR FOZ B BRAUN MELSUNGEN AG 25A26G8262

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown