BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 911747 · Received September 12, 2007

    Report

    Report Number
    2523676-2007-00055
    Event Type
    Other
    Date Received
    September 12, 2007
    Date of Event
    August 15, 2007
    Report Date
    August 31, 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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL INTROCAN SAFETY NEEDLE WITH CLIP INVOLVED IN THE INCIDENT WAS RETURNED TO THE MFR TO BE EVALUATED. THE CLIP WAS LOCATED AT THE TIP OF THE NEEDLE. HOWEVER, THE CLIP DID NOT COVER THE TIP OF THE NEEDLE. THE LONG ARM OF THE CLIP WAS PUSHED OFF THE SIDE OF THE NEEDLE. THE CATHETER WAS NOT RETURNED FOR EVAL. ON 09/11/07 - THE FACILITY WAS CONTACTED TO INFORM THEM THAT THE RETURNED SAMPLE DID NOT HAVE THE CLIP COVERING THE TIP OF THE NEEDLE AS INITIALLY REPORTED. THE REPORTER INDICATED THAT THE NURSE DID NOT RECEIVE A NEEDLESTICK. THE NURSE DISTINCTLY FELT THE SIDE OF THE CLIP PUNCTURE HER SKIN. ALL SAFETY CLIP DIMENSIONS THAT WERE ABLE TO BE MEASURED ON THE RETURNED SAMPLE WERE CHECKED AND FOUND TO BE WITHIN THE DESIGN SPECIFICATIONS. THE SAFETY CLIP IS DESIGNED TO COVER THE TIP OF THE NEEDLE, HOWEVER, THIS PORTION OF THE NEEDLE IS MADE OF RIGID METAL AND SHOULD STILL NOT BE HANDLE AFTER THE CLIP IS ACTIVATED. 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 INFO HAS BEEN PROVIDED TO THE ACTUAL MFR, B. BRAUN MEDICAL INDUSTRIES SDN BHD, IN MALAYSIA.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: NURSE USING INTROCAN. INSERTION AND REMOVAL OF THE STYLET WITHOUT INCIDENT, SAFETY CLIP ENGAGED. REPORTED SAFETY CLIP PUNCTURED SKIN. ADDITIONAL INFO PROVIDED BY THE FACILITY INDICATED THE NURSE IS FINE AND ALL PROTOCOL BLOOD WORK TESTING IS NEGATIVE. THE LOT NUMBER REMAINS UNKNOWN. NO FURTHER INFO 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other