BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 957420 · Received November 28, 2007

    Report

    Report Number
    2523676-2007-00100
    Event Type
    Other
    Date Received
    November 28, 2007
    Date of Event
    October 22, 2007
    Report Date
    November 15, 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
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER TO BE EVALUATED. 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 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 SALES REP. PER THE USER FACILITY: AFTER STARTING IV AND CLEANING UP NURSE WAS STUCK BY INTROCAN STYLET. THE SHIELD HAD SHIFTED OFF THE NEEDLE. CUSTOMER DID NOT SAVE SAMPLE. NURSE FOLLOWED WITH EMPLOYEE HEALTH PER FACILITY PROTOCOL. ADDITIONAL INFORMATION PROVIDED BY THE USER FACILITY INDICATED THAT ALL PROTOCOL BLOODWORK TESTING PERFORMED HAS BEEN NEGATIVE TO DATE. THE SAMPLE WAS DISCARDED. THE SALES REP REPORTED THE LOT NUMBER IS 7D15258W27.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MEDICAL, INC. NA 7D15258W27

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other