BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN SAFETY®

    MDR report key: 21746700 · Received April 1, 2025

    Report

    Report Number
    9610825-2025-00194
    Event Type
    Injury
    Date Received
    April 1, 2025
    Date of Event
    February 18, 2025
    Report Date
    April 1, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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). 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 INFO: PREMARKET SUBMISSION # K020785. K021094. K220626. UDI NUMBER: (B)(4). DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR OF THE COMPLAINT BATCH 24E28G8911 AND NO ABNORMALITY OBSERVED DURING IN-PROCESS AND FINAL CONTROL INSPECTION. NO SAMPLE RETURNED AS IT WAS DISCARDED. CUSTOMER PROVIDED A PICTURE OF A WHITE GAUZE PAD WITH A SMALL AMOUNT OF RED BLOOD ON IT BUT UNFORTUNATELY, THE PICTURE IS NOT CLEAR. ROOT CAUSE ANALYSIS: RECEIVE 1 PICTURE OF WHITE GAUZE WITH A SMALL AMOUNT OF BLOOD ON IT. FROM THE PICTURE, IT IS UNCLEAR THAT IS THERE ANY TEAR OFF CAPILLARY. NEVERTHELESS, BASED ON THE CUSTOMER COMPLAINT INFORMATION, THE FOREIGN BODY IS ACTUALLY A THROMBUS. CONCLUSION: BASED ON THE CUSTOMER DESCRIPTION, THIS COMPLAINT WILL BE CONCLUDED AS NOT CONFIRMED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: "PATIENT REPORTS DISCOMFORT BY FOREIGN BODY IN THE ELBOW, AFTER THE REMOVAL OF A CATHETER NUMBER 22, IS REFERRED TO VALIDATE THE CLINICAL CONDITION, THEY PERFORM AN ULTRASOUND WHERE THEY DETECT FOREIGN BODY, ARE WAITING FOR THE IDENTIFICATION OF THE FOREIGN BODY BY THE CLINIC CES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579269 INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ B BRAUN MELSUNGEN AG 4251628-04 24E28G8911

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention