BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 1120714 · Received August 14, 2008

    Report

    Report Number
    2523676-2008-00071
    Event Type
    Other
    Date Received
    August 14, 2008
    Date of Event
    July 10, 2008
    Report Date
    August 7, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT HAS NOT YET BEEN RETURNED TO THE MFR TO BE EVALUATED. WITHOUT THE SAMPLE A THOROUGH EVAL COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. IT WOULD 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 THAT THE PRODUCT FUNCTIONED PROPERLY, HOWEVER, THE NEEDLE WAS NOT DISPOSED OF IMMEDIATELY AND DURING CLEANUP THE NEEDLE CLIP WAS SOMEHOW MANIPULATED AND EXPOSED THE NEEDLE, RESULTING IN A NEEDLESTICK. ALL AVAILABLE INFO HAS BEEN PROVIDED TO THE ACTUAL MFR.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: IV START UNSUCCESSFUL, THE STYLET WAS REMOVED FROM CATHETER, CLIP ENGAGED AT TIP, NURSE PLACED PRODUCT TO SIDE IN PACKAGING. WHEN PICKED UP, THE CLIP "WAS NOT ON THE END" OF THE STYLET. NURSE SUSTAINED NEEDLESTICK INJURY. FACILITY PROTOCOL FOLLOWED. PT WAS POSITIVE FOR (B) (6). ADDITIONAL INFO PROVIDED BY THE FACILITY INDICATED THE NURSE IN THE INCIDENT HAD INITIAL BASELINE BLOODWORK TESTING DONE. THE NURSE IS DUE TO HAVE 6 WEEK BLOODWORK TESTING PERFORMED. THERE WILL BE A 12 WEEK FOLLOW-UP TESTING AND 6 MONTH FOLLOW-UP TESTING PERFORMED. THE SAMPLE WILL BE SENT FOR EVAL BY THE SALES REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MEDICAL, INC. NA 8A14258306

    Patients

    Seq Age Sex Outcome Treatment
    1 Other