BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 1474578 · Received June 29, 2009

    Report

    Report Number
    2523676-2009-00040
    Event Type
    Malfunction
    Date Received
    June 29, 2009
    Date of Event
    April 12, 2009
    Report Date
    June 23, 2009
    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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS DISCARDED AND WAS NOT MADE AVAILABLE TO THE MANUFACTURER TO BE EVALUATED AND A LOT NUMBER WAS NOT REPORTED. WITHOUT THE SAMPLE AND A LOT NUMBER 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 FOR EVALUATION.

    Description of Event or Problem · 1

    AS REPORTED BY THE REGIONAL MANAGER PER THE USER FACILITY: "WE HAD A NURSE STUCK WHEN THE SAFETY DEVICE DID NOT ENGAGE AS IT SHOULD HAVE. THIS WAS A SEASONED NURSE WHO WAS VERY FAMILIAR WITH THE PRODUCT AND HAS BEEN USING IT SINCE IT WAS IMPLEMENTED HERE A YEAR OR SO AGO. I DO NOT HAVE THE DEFECTIVE PRODUCT OR LOT NUMBER. INJURY OCCURRED AFTER IV INSERTED, REGULAR HOSPITAL PROTOCOL FOLLOWED POST NEEDLE STICK". ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THE NURSE INVOLVED IN THE INCIDENT RECEIVED PROTOCOL BLOODWORK TESTING AND AS FAR AS THE REPORTER KNOWS, ALL RESULTS HAVE BEEN NEGATIVE. SHE REPORTED THIS TO BE AN ISOLATED INCIDENT. THE SAMPLE WAS DISCARDED AND THE LOT NUMBER REMAINS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other