BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 868720 · Received May 14, 2007

    Report

    Report Number
    2523676-2007-00021
    Event Type
    Other
    Date Received
    May 14, 2007
    Date of Event
    March 2, 2007
    Report Date
    April 20, 2007
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL INTROCAN SAFETY NEEDLE WITH CLIP INVOLVED IN THE INCIDENT WAS RETURNED FOR EVAL. THE SAFETY CLIP WAS LOCATED ON THE SHAFT OF THE NEEDLE AND HAD NOT DEPLOYED TO THE TIP. THE CATHETER WAS NOT RETURNED. ALL SAFETY CLIP DIMENSIONS THAT WERE ABLE TO BE MEASURED ON THE RETURNED SAMPLE WERE CHECKED AND FOUND TO BE WITHIN THE DESIGN SPECIFICATIONS. IT SHOULD BE NOTED THAT THE INTROCAN SAFETY IS DESIGNED TO REDUCE THE RISK OF NEEDLESTICK INJURIES. HOWEVER CDC GUIDELINES AND/OR FACILITY PROTOCOLS SHOULD ALWAYS BE FOLLOWED. SHARPS SHOULD BE DISPOSED OF IMMEDIATELY INTO AN APPROPRIATE SHARPS CONTAINER. THE SAMPLE AND ALL AVAILABLE INFO HAS BEEN PROVIDED TO THE ACTUAL MFR, B. BRAUN MEDICAL INDUSTRIES SDN BHD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MEDICAL, INC. NA 6H01258R02

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other