BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 1221813 · Received November 5, 2008

    Report

    Report Number
    2523676-2008-00089
    Event Type
    Other
    Date Received
    November 5, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 28, 2008
    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
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS NOT RETURNED TO THE MANUFACTURER TO BE EVALUATED. WITHOUT THE 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 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: INTROCAN CLIP FAILURE. WHEN STYLET WAS WITHDRAWN, THE CLIP CAME OFF THE TIP AND RN STUCK BY NEEDLE. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THAT THE NURSE INVOLVED IN THE INCIDENT DID RECEIVE THE FACILITIES PROTOCOL BLOOD WORK TESTING AND TO DATE ALL RESULTS ARE 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 8C04258302

    Patients

    Seq Age Sex Outcome Treatment
    1 Other