BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 7952822 · Received October 10, 2018

    Report

    Report Number
    9610825-2018-00209
    Event Type
    Malfunction
    Date Received
    October 10, 2018
    Report Date
    October 10, 2018
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DYB
    PMA / PMN Number
    K021094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 EVENT TWO OF B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. MULTIPLE ATTEMPTS WERE MADE TO GET ADDITIONAL INFORMATION ON THE REPORTED INCIDENT, INCLUDING THE ITEM AND BATCH NUMBERS OF THE PRODUCT INVOLVED IN THE INCIDENT, HOWEVER NO ADDITIONAL INFORMATION WAS PROVIDED. WITHOUT THE ACTUAL SAMPLE AND NO ITEM AND BATCH INFORMATION A THOROUGH ROOT CAUSE ANALYSIS COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: EVENT 2 AFTER A FAILED ATTEMPT TO PLACE THE CATHETER, THE NURSE REMOVED THE CATHETER AND THE SAFETY MECHANISM DID NOT ENGAGE. THE PATIENT THEN PICKED UP THE CATHETER AND STABBED TWO SECURITY GUARDS. NOTE: TWO REPORTS ARE BEING FILED, ONE FOR EACH SECURITY GUARD INVOLVED IN THE INCIDENT. THIS IS THE REPORT FOR THE SECOND SECURITY GUARD; REPORT 9610825-2018-00208 WILL BE FILED FOR THE FIRST SECURITY GUARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795151 INTROCAN SAFETY® INTRODUCER, CATHETER DYB B. BRAUN MELSUNGEN AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1