BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN SAFETY®

    MDR report key: 21605915 · Received March 14, 2025

    Report

    Report Number
    9610825-2025-00127
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    February 26, 2025
    Report Date
    March 25, 2025
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    UDI-DI
    04046963165949
    PMA / PMN Number
    K020785
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE (1) SAMPLE WAS SUBMITTED TO THE MANUFACTURER FOR EVALUATION. THROUGH VISUAL EXAMINATION, IT WAS OBSERVED THAT THE CAPILLARY HAD TORN OFF AND EXHIBITED A V-SHAPE CUT AT THE TEAR OFF AREA. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NONCONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. THIS PRODUCT IS ASSEMBLED ON AN AUTOMATED ASSEMBLY MACHINES EQUIPPED WITH 100% VISION SYSTEMS AND TEST STATIONS. DEFECTIVE PRODUCT WILL BE DETECTED BY VISION SYSTEM AND BE REJECTED AUTOMATICALLY BY MACHINES. THE ASSEMBLY PROCESS CARDS SHOW NO ABNORMALITIES. BASED ON THE INVESTIGATION, A V-SHAPE CUT IS LIKELY CAUSED BY REINSERTION. THEREFORE, THE DEFECT IS DUE TO AN APPLICATION ERROR AND THE COMPLAINT IS CONSIDERED NOT 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.

    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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED DURING A LIVE CALL THE INTROCAN SAFETY FEP 22G, 0.9X25MM-US BROKE OFF IN A PATIENT VEIN DURING INSERTION. NURSE ATTEMPTED TO INSERT THE DEVICE - BLOOD WAS RETURNED SO SHE REMOVED THE NEEDLE. WHEN THE NURSE TRIED THE FLUSH THE DEVICE, SHE WAS NOTED IT WAS NOT IN AND THEN REMOVED THE DEVICE, AND ONLY HALF OF THE DEVICE CAME OUT - THE OTHER HALF WAS IN THE PATIENT VEIN. THIS MORNING THE PATIENT WAS GOING TO BE TAKEN DOWN FOR IMAGING TO DETERMINE FURTHER PATIENT CARE AND MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399902 INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ B. BRAUN MELSUNGEN AG 23H14G8261 04046963165949

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention