BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 780619 · Received November 10, 2006

    Report

    Report Number
    2523676-2006-00093
    Event Type
    Other
    Date Received
    November 10, 2006
    Date of Event
    October 12, 2006
    Report Date
    October 23, 2006
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FOZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER TO EVALUATE. WITHOUT THE ACTUAL SAMPLE A THOROUGH EVALUATION 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 PROTOCOL 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: THE NURSE INSERTED AN IV INTO AN AGITATED COMBATIVE PATIENT. THE STYLET WAS REMOVED AND PLACED ASIDE; THE SAFETY DEVICE DID NOT ENGAGE. THE NURSE WAS NOT AWARE THAT THE SAFETY DEVICE DID NOT ENGAGE. AS SHE WAS CLEANING UP THE AREA SHE SUSTAINED A NEEDLE STICK. IT WAS AT THAT TIME SHE BECAME AWARE THAT THE SAFETY DEVICE DID NOT ENGAGE. NEEDLE STICK PROTOCOL WAS INITIATED. ADDITIONAL INFORMATION PROVIDED BY THE USER FACILITY INDICATED THAT ALL PROTOCOL BLOODWORK TESTING WAS NEGATIVE. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MEDICAL, INC. NA 5M05258N05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other