BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN SAFETY®

    MDR report key: 8457975 · Received March 27, 2019

    Report

    Report Number
    9610825-2019-00074
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    February 21, 2019
    Report Date
    June 26, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DYB
    UDI-DI
    04046963165901
    PMA / PMN Number
    K021094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018. B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER 400422455. ONE USED SAMPLE WAS RECEIVED FOR EVALUATION. THE CATHETER WAS BROKEN OFF, AND THE BROKEN AREA OF THE CATHETER EXHIBITED A CLEAR "V" SHAPE. THIS PRODUCT IS SUBJECTED TO A 100% INSPECTION BY AN IN-LINE VISION SYSTEM THAT IS CALIBRATED AND SUBJECTED TO REGULAR VERIFICATIONS TO ENSURE IT IS FUNCTIONING PROPERLY. THE DEFECT OBSERVED IN THE RETURNED SAMPLE WOULD HAVE BEEN DETECTED AND REJECTED BY THE IN-LINE VISION SYSTEM. DUE TO THE CLEAR "V" SHAPE PRESENT ON THE BROKEN CATHETER THE MOST LIKELY CAUSE OF THE REPORTED ISSUE IS THE REINSERTION OF THE NEEDLE INTO THE CATHETER. THE IFU CLEARLY STATES, "AFTER WITHDRAWAL, DO NOT REINTRODUCE THE STEEL NEEDLE INTO THE CATHETER, AS THE LATTER MAY BE CUT OFF". NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: THE PATIENT HAD THE IV IN THEIR AC (NOT SURE WHICH ARM) AND THE CATHETER PORTION BROKE OFF IN THE VEIN. THIS PATIENT HAD TO GO TO SURGERY TO HAVE THE CATHETER PORTION REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251199 INTROCAN SAFETY® INTRODUCER, CATHETER DYB B. BRAUN MELSUNGEN AG 4252560-02 04046963165901

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention