BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 896774 · Received August 13, 2007

    Report

    Report Number
    2523676-2007-00045
    Event Type
    Other
    Date Received
    August 13, 2007
    Date of Event
    July 9, 2007
    Report Date
    August 6, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MFR TO BE EVALUATED. WITHOUT THE ACTUAL SAMPLE A THOROUGH EVAL COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. 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 INFO HAS BEEN PROVIDED TO THE ACTUAL MFR, B. BRAUN MEDICAL INDUSTRIES.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: "AN EMPLOYEE SUFFERED A NEEDLESTICK WHEN THEY ATTEMPTED TO RETRACT THE NEEDLE INTO THE SAFETY MECHANISM FOLLOWING INSERTION OF AN IV. THE PROBLEM WAS THAT THE NEEDLE WOULDN'T RETRACT-IT STUCK IN THE MECHANISM. ADD'L INFO PROVIDED BY THE FACILITY INDICATED THE NURSE IS FINE. ALL PROTOCOL BLOODWORK TESTING RESULTS ARE NEGATIVE. THE SAMPLE HAS BEEN DISCARDED AND WILL NOT BE SENT FOR EVAL. THE FACILITY HAS REPORTED THAT A B. BRAUN REP CAME TO THE FACILITY AND PROVIDED ADD'L IN-SERVICE TRAINING FOR THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MEDICAL, INC. NA 6I30258N04

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other