BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 731643 · Received June 30, 2006

    Report

    Report Number
    2523676-2006-00052
    Event Type
    Other
    Date Received
    June 30, 2006
    Date of Event
    May 25, 2006
    Report Date
    June 27, 2006
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FOZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 EVALUATION. 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. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED TO THE ACTUAL MANUFACTURER, B. BRAUN MEDICAL INDUSTRIES SDN BHD, IN MALAYSIA.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: IV WAS STARTED AND THE STYLET WAS LAID DOWN. THE CLIP WAS ONLY 3/4 UP ON THE NEEDLE. WHEN IT WAS PICKED UP A NEEDLE STICK WAS RECEIVED. THE FACILITY DECLINED ANY INFORMATION REGARDING THE PROTOCOL BLOODWORK TEST RESULTS. THE LOT NUMBER REMAINS UNK. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other