BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN SAFETY®

    MDR report key: 21813615 · Received April 10, 2025

    Report

    Report Number
    9610825-2025-00210
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    March 19, 2025
    Report Date
    May 2, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Adverse Event
    Yes
    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 INTERNAL REPORT NUMBER (B)(4). 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 K021094 K220626 ADDITIONAL INFORMATION: D9 DEVICE RETURNED TO MANUFACTURER DEVICE HISTORY RECORD (DHR): REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 24D26G8932 AND THERE WAS NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. SAMPLE EVALUATION: RECEIVED 1 (ONE) USED AND CONTAMINATED CAPILLARY HUB OF A INTROCAN SAFETY-W FEP 22G, 0.9X25MM-AP WITHOUT PACKAGING. ATTACHED WITH THE RETURNED USED SAMPLE WAS AN EXTENSION SET, PRESUMABLY USED WITH THE INTROCAN. CANNULA HUB AND PROTECTIVE CAP WERE NOT BEING RETURNED FOR INVESTIGATION. UPON VISUAL INSPECTION, THE RETURNED CAPILLARY WAS OBSERVED TO BE DAMAGED / TEAR OFF. ROOT CAUSE ANALYSIS: SIMULATION 1: A SIMULATION WAS CONDUCTED BY CUTTING A CAPILLARY TO A SHORTER LENGTH AND TEST AT BOTH CAL AND ECM MACHINE VISION SYSTEM. THE SAMPLE WAS ABLE TO BE DETECTED AND WAS REJECTED. SIMULATION 2: SIMULATION 2 WAS CONDUCTED PURPOSELY TO TRY TO BREAK OFF THE CAPILLARY UNDER DIFFERENT SCENARIOS. SCENARIO 1 # PIERCE BY CANNULA A SIMULATION WAS CONDUCTED BY USING A GOOD PART AND PIERCING THE CAPILLARY WITH CANNULA AND LATER TEARING OFF THE CAPILLARY. THIS DEFECT IS SIMILAR TO CANNULA REINSERTION WHERE THE CANNULA WOULD PIERCE THE CAPILLARY AND CAUSE IT TO BREAK APART. THE SIMULATION SAMPLE WAS TAKEN FOR INSPECTION AND OBSERVED THAT DEFECT CREATED. THE CAPILLARY BROKEN AREA EXHIBITS A CLEAR "V" SHAPE CUT FROM THE CANNULA BEVEL. IN SOME CASES, THE V-SHAPE CUT COULD BE DISTORTED DUE TO THE REMOVAL OF CANNULA AFTER THE PIERCED. SCENARIO 2 # CUT BY SHARP TOOL A GOOD SAMPLE CAPILLARY WAS CUT BY SHARP TOOL AND TAKEN FOR INSPECTION. THE CUT AREA SHOWS A CLEAN CUT OF THE CAPILLARY. AS COMMUNICATED IN IFU, WARNING SECTION STATED THAT: - DO NOT RE-USE. RE-USE OF SINGLE-USE DEVICES CREATES A POTENTIAL RISK FOR PATIENT OR USER. IT MAY LEAD TO CONTAMINATION AND/OR IMPAIRMENT OF FUNCTIONAL CAPABILITY. CONTAMINATION AND/OR LIMITED FUNCTIONALITY OF THE DEVICE MAY LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. - IN THE CASE OF AN UNSUCCESSFUL IV CATHETER PLACEMENT ATTEMPT, REMOVE THE NEEDLE FIRST, THEN REMOVE THE CATHETER FROM PATIENT AND DISCARD BOTH. - NEVER REINSERT THE NEEDLE INSIDE THE CATHETER ONCE THE NEEDLE HAS BEEN PARTIALLY OR COMPLETELY WITHDRAWN AS IT MAY PIERCE AND/OR SEVER THE CATHETER. - EXTREME CARE SHOULD BE TAKEN NOT TO DAMAGE, PIERCE, CUT AND SEVER THE CATHETER. THEREFORE, DO NOT BEND THE CATHETER AND/OR NEEDLE DURING INSERTION, ADVANCEMENT, OR REMOVAL OF THE NEEDLE. - DO NOT USE SCISSORS OR SHARP INSTRUMENTS AT OR NEAR THE INSERTION SITE. CONCLUSION: BASED ON THE RECEIVED SAMPLE, THE SAMPLE WAS A USED SAMPLE AND THE TEAR OFF CAPILLARY AREA EXHIBITS V-CUT SHAPE AND DISTORTION AS A RESULT OF BEING CUT BY THE CANNULA BEVEL. THE DEFECT IS NOT CAUSED BY MANUFACTURING PROCESS. THUS, THIS COMPLAINT WILL BE CONCLUDED AS DEFECT DUE TO WRONG HANDLING AND JUSTIFIED AS CONFIRMED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. 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 INFORMATION: UDI NUMBER (B)(4). PREMARKET SUBMISSION #: K020785; K021094; K220626.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: ON (B)(6) 2025, UNDER GENERAL ANESTHESIA, AN INDWELLING NEEDLE WAS INSERTED INTO THE LEFT RADIAL ARTERY. THE PATIENT'S SURGERY ENDED AT 18:50, AND AT 21:00, THE NURSE FOUND THAT THE CAPILLARY WAS BROKEN WHEN REMOVING THE INDWELLING NEEDLE. CUT OPEN THE LEFT RADIAL ARTERY UNDER LOCAL ANESTHESIA AND REMOVE THE BROKEN CAPILLARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415483 INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ B BRAUN MELSUNGEN AG 4254511-03 24D26G8392

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention