BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 1062856 · Received June 18, 2008

    Report

    Report Number
    2523676-2008-00054
    Event Type
    Other
    Date Received
    June 18, 2008
    Date of Event
    May 19, 2008
    Report Date
    June 10, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS RETURNED TO THE MANUFACTURER TO BE EVALUATED. ONE USED 20 GA. INTROCAN SAFETY STYLET WITH THE SAFETY CLIP COVERING THE NEEDLE TIP WAS RETURNED. THE LONG ARM OF THE CLIP APPEARED BENT AND DAMAGED. DUE TO THE DAMAGE ON THE LONG ARM OF THE CLIP THE LONG ARM CLIP DIMENSION COULD NOT BE ACCURATELY MEASURED. ALL OTHER SAFETY CLIP DIMENSIONS THAT WERE ABLE TO BE MEASURED ON THE RETURNED SAMPLE WERE CHECKED AND FOUND TO BE WITHIN THE DESIGN SPECIFICATIONS. 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. THE SAMPLE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED TO THE ACTUAL ANOTHER COUNTRY'S MANUFACTURER.

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP PER THE USER FACILITY: NURSE HAD COMPLETED IV START AND WAS CLEANING UP FROM PROCEDURE WHEN STICK OCCURRED. NEEDLESTICK INJURY, REPORTS NORMAL FACILITY POST EXPOSURE PROTOCOL FOLLOWED. ADDITIONAL INFORMATION PROVIDED BY THE USER FACILITY INDICATED THE NURSE SUFFERED NO ADVERSE SEQUELA ASSOCIATED WITH THE INCIDENT. ALL PROTOCOL BLOODWORK TESTING PERFORMED WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V SAFETY CATHETER FOZ B. BRAUN MEDICAL, INC. NA 7D06258R55

    Patients

    Seq Age Sex Outcome Treatment
    1 Other