BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN SAFETY®

    MDR report key: 8383300 · Received March 1, 2019

    Report

    Report Number
    9610825-2019-00033
    Event Type
    Injury
    Date Received
    March 1, 2019
    Date of Event
    January 20, 2019
    Report Date
    April 4, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DYB
    UDI-DI
    04046963318178
    PMA / PMN Number
    K021094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. ATTEMPTS TO GET ADDITIONAL INFORMATION AND TO RECEIVE THE DEVICE INVOLVED IN THE REPORTED EVENT ARE BEING MADE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018. (B)(4) (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 400420181. THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. A SIMULATION OF THE REPORTED DEFECT WAS CREATED WITH A RETAIN SAMPLE, AND THE IN-LINE VISION SYSTEM WAS ABLE TO DETECT AND REJECT THE DEFECTIVE SAMPLE. 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 REPORTED WOULD HAVE BEEN DETECTED AND REJECTED BY THE IN-LINE VISION SYSTEM. BASED ON THE RESULTS OF THE INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. 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.

    Description of Event or Problem · 0

    AS REPORTED ON MEDWATCH MW5083446: UPON REMOVAL OF PERIPHERAL IV CATHETER IN THIS PATIENT'S LEFT ARM,THE CATHETER TIP WAS MISSING AND REMAINED IN PATIENT'S ARM. PATIENT NEEDED TO BE TAKEN TO THE OPERATING ROOM LATER THAT NIGHT TO HAVE THE CATHETER TIP REMOVED SURGICALLY, AND THIS WAS SUCCESSFUL. PATIENT DOING WELL AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174334 INTROCAN SAFETY® INTRODUCER, CATHETER DYB B. BRAUN MELSUNGEN AG 4252520-02 UNKNOWN 04046963318178

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention