BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 21796200 · Received April 8, 2025

    Report

    Report Number
    9610825-2025-00202
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    March 10, 2025
    Report Date
    April 22, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    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: PREMARKET SUBMISSION # K021094, K220626. UDI NUMBER (B)(4).

    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: PREMARKET SUBMISSION # K021094, K220626. UDI NUMBER (B)(4). INVESTIGATION RESULT BASED ON THE FEEDBACK AND SAMPLE PROVIDED. DEVICE HISTORY RECORD (DHR): REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 23L28G8911 AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. SAMPLE FOR EVALUATION: RECEIVED 1 USED AND CONTAMINATED CAPILLARY HUB OF INTROCAN SAFETY PUR 24G, 0.7X19MM-AP ATTACHED TO AN EXTENSION SET WITHOUT PACKAGING. NO CANNULA HUB AND PROTECTIVE CAP WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION: BASED ON THE OBSERVATION, THE CAPILLARY EXHIBIT V-CUT PIERCED. REVIEWED ASSEMBLY PROCESS: THIS PRODUCT LINE IS ASSEMBLED ON AUTOMATIC ASSEMBLY MACHINES EQUIPPED WITH 100% VISION INSPECTION SYSTEM AND TEST STATIONS. ALONG THE MACHINES, THERE IS 100% INSPECTION ON THE CONDITION OF THE CATHETER TIP. PARTS FOUND OUT OF THE INSPECTION CRITERIA WILL BE DETECTED AND BE REJECTED AUTOMATICALLY BY MACHINES. THE MANUFACTURING PROCESS CARDS SHOWS NO ABNORMALITY FOR THE COMPLAINT BATCH. INSTRUCTION FOR USE (IFU) STATEMENT: 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 TO ACTIVATE SAFETY MECHANISM, THEN REMOVE 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 OR 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: THE COMPLAINT SAMPLE SHOWS EVIDENCE OF V-CUT SHAPE AT THE PIERCED AREA AS A RESULT OF BEING CUT BY THE CANNULA BEVEL. THE DEFECT IS NOT CAUSED BY MANUFACTURING PROCESS. WE CONCLUDED THIS TO BE AN APPLICATION ERROR. COMPLAINT IS CONFIRMED.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: AFTER ONE DAY OF RETENTION, IT WAS DISCOVERED THAT THE CAPILLARY WAS LEAKING. UPON CAREFUL OBSERVATION, IT WAS FOUND THAT THE CAPILLARY WAS BROKEN NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768804 INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ B BRAUN MELSUNGEN AG 4251601-03 23L28G8911

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown