BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 877209 · Received July 9, 2007

    Report

    Report Number
    2523676-2007-00036
    Event Type
    Other
    Date Received
    July 9, 2007
    Date of Event
    June 11, 2007
    Report Date
    June 29, 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
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER TO EVALUATE AND A CATALOG NUMBER OR LOT NUMBER HAVE NOT BEEN PROVIDED. WITHOUT THE ACTUAL SAMPLE, CATALOG NUMBER OR LOT NUMBER A THROUGH 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP PER USER FACILITY: NURSE SET STYLET DOWN AFTER COMPLETING IV STICK. WHEN SHE PICKED EVERYTHING UP THE STYLET WAS CAUGHT IN THE GAUZE AND SHE RECEIVED A NEEDLE STICK. CUSTOMER DOES NOT KNOW REFERENCE NUMBER OR LOT NUMBER. KNOWS IT OCCURRED THIS YEAR. THE NEEDLE STICK REQUIRED FOLLOW UP. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THE INCIDENT OCCURED IN 2007 AND THERE IS NO ADDITIONAL INFORMATION REGARDING THE ITEM NUMBER OR THE LOT NUMBER OF THE PRODUCT. THE SAMPLE HAS SINCE BEEN DISCARDED AND WILL NOT BE SENT FOR EVALUATION AS PREVIOUSLY REPORTED. IT HAS BEEN REPORTED ALL PROTOCOL BLOODWORK TESTING RESULTS ARE CONFIDENTIAL AND ANY INFORMATION PERTAINING TO TESTING WILL NOT BE RELEASED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other