BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 21824783 · Received April 11, 2025

    Report

    Report Number
    9610825-2025-00241
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 4, 2025
    Report Date
    June 2, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: UDI NUMBER (B)(4). PREMARKET SUBMISSION # K021094, K220626

    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 # K021094, K220626. INVESTIGATION RESULTS: DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR FOR THE BATCH NUMBER 24E24G8363, NO ABNORMALITY WAS OBSERVED DURING IN-PROCESS INSPECTION AND FINAL CONTROL INSPECTION. SAMPLE FOR EVALUATION: RECEIVED ONE (1) PIECE OF AN USED AND CONTAMINATED CANNULA HUB FROM AN INTROCAN SAFETY PUR 24G, 0.7X19MM-JP IN AN OPENED PACKAGING FOR LOT 24E24G8363 AND MATERIAL# 4251601JP. VISUAL INSPECTION: NO DAMAGE OR DEFORMITY OBSERVED ON SAFETY CLIP ARM AND BACKWALL UNDER 20X MAGNIFICATION USING KEYENCE MICROSCOPE. FURTHER OBSERVED THE ANTI-ROTATIONAL PIN WAS DAMAGED, FOLDED AND GRIPPED THE SAFETY CLIP. INVESTIGATION RESULT: THE POTENTIAL ROOT CAUSES HAVE BEEN INVESTIGATED; THE DEFECT PRODUCED FROM THE SIMULATION SAMPLES ALSO WERE NOT SIMILAR WITH THE COMPLAINT SAMPLE. FURTHERMORE, THE COMPLAINT SAMPLES DAMAGE ALSO SHOWS NO SIMILARITY WITH THE GRIPPER BLOCK PROFILE AT STATION 14: CLIP ROTATION & VERTICAL POSITION. THIS COMPLAINT IS CONFIRMED.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: WHEN THE INNER NEEDLE WAS PULLED OUT, THE CLIP AT THE TIP DID NOT LATCH, LEAVING THE NEEDLE TIP PROTRUDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2440485 INTROCAN SAFETY® INTRODUCER, CATHETER DYB B BRAUN MELSUNGEN AG 4251601JP 24E24G8363

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown