BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY® 3

    MDR report key: 24209231 · Received January 29, 2026

    Report

    Report Number
    9610825-2026-00030
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    January 19, 2026
    Report Date
    February 26, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST
    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. 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: PREMARKET SUBMISSION # K213085.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). DEVICE HISTORY RECORD (DHR): REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 25H15G8952 AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. SAMPLE FOR EVALUATION: RECEIVED ONE (1) USED AND CONTAMINATED INTROCAN SAFETY 3 PUR 22G 0.9X25MM-EU WITHOUT PACKAGING. ATTACHED WITH THE RETURNED SAMPLE WAS AN EXTENSION SET. THE CANNULA HUB AND PROTECTIVE CAP WERE NOT RETURNED. VISUAL INSPECTION: OBSERVED THE CAPILLARY HAD BEEN TORN OFF. THE TEAR-OFF AREA OF THE CAPILLARY EXHIBITS A CLEAN-CUT SHAPE. THE BROKEN PIECE OF THE CAPILLARY WAS RETURNED FOR INVESTIGATION. AS COMMUNICATED IN IFU, WARNING SECTION STATED THAT: - EXTREME CARE SHOULD BE TAKEN NOTE TO DAMAGE, PIERCE, CUT OR SEVER THE CATHETER. - DO NOT USE SCISSORS OR SHARP INSTRUMENTS AT OR NEAR THE INSERTION SITE. REVIEWED ASSEMBLY PROCESS: THIS PRODUCT IS ASSEMBLED ON AUTOMATED ASSEMBLY MACHINES EQUIPPED WITH 100% VISION INSPECTION SYSTEM AND TEST STATIONS. WE HAVE THOROUGHLY INVESTIGATED AND SUCH NATURE OF DEFECT IS NOT ATTRIBUTED TO MANUFACTURING PROCESS. DAMAGE INDUCED AFTER THE ASSEMBLY PROCESS IS NOT POSSIBLE SINCE THE CATHETER HAS BEEN PROTECTED WITH A PROTECTIVE CAP. CONCLUSION: BASED ON THE SAMPLE RECEIVED, THE TEAR OFF CAPILLARY AREA SHOWS A CLEAN CUT. THIS DEFECT IS NOT DUE TO MANUFACTURING PROCESS. INFORMATION REGARDING THE PRODUCT'S USAGE BEYOND THE MANUFACTURING SITE REMAINS UNKNOWN. COMPLAINT IS 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: "WHEN REMOVING THE PERIPHERAL VENOUS CATHETER (PVC), THE CAPILLARY REPORTEDLY DETACHED FROM THE IS3 AND REMAINED INSIDE THE PATIENT. ACCORDING TO THE USER, THE CAPILLARY WAS VISIBLE FROM THE OUTSIDE AND COULD THEREFORE BE REMOVED ACCORDINGLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274151 INTROCAN SAFETY® 3 CATHETER,INTRAVASCULAR FOZ B BRAUN MELSUNGEN AG 25H15G8952

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown