BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN SAFETY®

    MDR report key: 18347165 · Received December 18, 2023

    Report

    Report Number
    9610825-2023-00613
    Event Type
    Injury
    Date Received
    December 18, 2023
    Report Date
    December 18, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    UDI-DI
    04046963185206
    PMA / PMN Number
    K020785
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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). NO SAMPLE AND/OR LOT NUMBER WERE PROVIDED. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE WITHOUT A SAMPLE AND/OR LOT NUMBER. THE ACTUAL DEFECTIVE DEVICE IS VALUABLE TOOL IN INVESTIGATING THE CAUSE OF THIS INCIDENT. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: CATHETER BROKEN OFF. DESCRIPTION - PIECE OF THE CATHETER BROKE OFF IN THE PATIENTS ARM AND HAD BEEN SURGICALLY REMOVED. PATIENT WAS ADMITTED TO THE HOSPITAL 8/18/2023 WHICH IV WAS STARTED. ON (B)(6) 2023 IV WAS REMOVED. ONCE PATIENT WAS RELEASED FROM HOSPITAL, HE WAS SENT HOME AND THE PLACE THE IV WAS GOT INFECTED. THEY HAD AN ULTRASOUND DONE AND FOUND A PIECE OF THE CATHETER IN HIS BASILIC VEIN (RIGHT ARM). ON (B)(6) 2023 SURGERY WAS PERFORMED TO REMOVE THE BROKEN PIECE. PATIENT WAS OKAY. MALE 61. UNABLE TO VERIFY WHICH CATHETER BROKE OFF. PART NUMBERS LISTED ARE 4252527-02 & 4251652-02 IN PATIENT RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58483 INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THE FOZ B. BRAUN MELSUNGEN AG 04046963185206

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention