BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 1032467 · Received April 16, 2008

    Report

    Report Number
    2523676-2008-00020
    Event Type
    Other
    Date Received
    April 16, 2008
    Date of Event
    March 15, 2008
    Report Date
    April 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
    FL, 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. HOWEVER, A LOT NUMBER AND ITEM NUMBER WERE NOT PROVIDED. THE NEEDLE WAS NOTED TO BE ENT ON A 45 DEGREE ANGLE AT THE HUB AND THE CLIP WAS OFF THE SIDE OF THE NEEDLE NEAR THE TIP. 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. IT APPEARS FROM THE EVENT DESCRIPTION AND ADDITIONAL INFORMATION PROVIDED BY THE FACILITY, THAT THE PRODUCT FUNCTIONED PROPERLY. HOWEVER, THE FORCE OF THE NEEDLE HITTING THE SHARPS CONTAINER BENT THE NEEDLE AND MANIPULATED THE CLIP, EXPOSING THE NEEDLE, RESULTING IN A NEEDLESTICK. THE SAMPLE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED TO THE ACTUAL MANUFACTURER, B. BRAUN MEDICAL INDUSTRIES (B) (4), IN (B) (4).

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP PER THE FACILITY: REPORTS ISSUE IS WITH INTROCAN CATHETER, GAGE SIZE AND LENGTH UNKNOWN. REPORTS NURSE STARTED IV, WITHDREW STYLET. NOTED CLIP WAS NOT FULLY DEPLOYED. IT WAS PART WAY DOWN STYLET. NURSE WAS DISPOSING OF THE SHARP, IT BOUNCED OUT OF THE SHARPS CONTAINER AND STUCK HER IN THE HAND. NEEDLE STICK PROTOCOL FOR THE FACILITY FOLLOWED BY NURSE. ADDITIONAL INFORMATION/CORRECTION, PROVIDED BY THE SALES REP PER THE NURSE INVOLVED IN THE INCIDENT, INDICATED WHEN STYLETTE PULLED OUT OF THE CATHETER, THE CLIP WAS OVER THE TIP. WHEN PLACING THE STYLETTE IN THE SHARPS CONTAINER, SHE BUMPED IT INTO THE SHARPS CONTAINER, FELT A PINCH, AND NOTICED THAT THE CLIP WAS HALFWAY DOWN THE SHAFT OF THE STYLETTE, AND WAS STUCK BY THE STYLETTE. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED TO DATE ALL PROTOCOL BLOOD WORK TESTING HAS BEEN NEGATIVE THE LOT NUMBER AND THE ITEM NUMBER REMAIN 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other