BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 1062850 · Received June 18, 2008

    Report

    Report Number
    2523676-2008-00055
    Event Type
    Other
    Date Received
    June 18, 2008
    Date of Event
    May 16, 2008
    Report Date
    June 9, 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

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS DISCARDED AND WAS NOT RETURNED TO THE MANUFACTURER TO BE EVALUATED. WITHOUT THE SAMPLE, A THOROUGH EVALUATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSION 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 HAVE 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 (B) (4), IN (B) (4).

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP PER THE USER FACILITY: CLIP DID NOT ACTIVATE WHEN WITHDRAWN FROM HUB AND NURSE STUCK HERSELF AFTER IV START. NORMAL FACILITY POST EXPOSURE PROTOCOL FOLLOWED. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THE NURSE IS FINE AND ALL PROTOCOL BLOODWORK TESTING PERFORMED HAS BEEN 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 7B12258N27

    Patients

    Seq Age Sex Outcome Treatment
    1 Other