BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN SAFETY

    MDR report key: 3896921 · Received June 4, 2014

    Report

    Report Number
    2523676-2014-00216
    Event Type
    Injury
    Date Received
    June 4, 2014
    Report Date
    May 22, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN(B)(6)): PRE-TERM BABY IN SPECIAL CARE BABIES UNIT BECAME SEPTIC STAFF NOTICED A LITTLE CUT/NICK ON HIS HAND UNDER THE CANNULA HUB. HOSPITAL THIS CUT WAS CAUSED BY THE CANNULA HUB, RESULTING IN SEPSIS. THE BABY REQUIRED IV ANTIBIOTICS. MFR # 9610825-2014-00216.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327889 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other