BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 2020523 · Received February 16, 2011

    Report

    Report Number
    2523676-2011-00006
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 18, 2010
    Report Date
    February 8, 2011
    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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS DISCARDED AND WAS NOT RETURNED TO THE MFR TO BE EVALUATED. WITHOUT THE ACTUAL SAMPLE A THOROUGH EVAL COULD NOT BE PERFORMED. IT HAS BEEN REPORTED THAT THE NURSE FINISHED THE IV AND SET THE NEEDLE DOWN AND DURING CLEAN UP SHE RECEIVED A NEEDLESTICK IN HER FINGER. IT IS POSSIBLE, THAT THE NEEDLE CLIP WAS SOMEHOW MANIPULATED AND EXPOSED THE NEEDLE DURING CLEANUP, RESULTING IN A NEEDLESTICK. HOWEVER, SINCE IT HAS BEEN REPORTED IT IS UNK IF THE CLIP COVERED THE NEEDLE BEFORE SETTING IT DOWN, NO SPECIFIC CONCLUSIONS 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 ALWAYS BE FOLLOWED. SHARPS SHOULD BE DISPOSED OF IMMEDIATELY INTO AN APPROPRIATE SHARPS CONTAINER. THERE ARE NO OTHER REPORTS OF THIS NATURE AGAINST THE LOT NUMBER. ALL AVAILABLE INFO HAS BEEN PROVIDED TO THE ACTUAL MFR FOR EVAL.

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP PER THE USER FACILITY: REPORTS CLIP DID NOT ACTIVATE, HAD A NEEDLE STICK IN THE ED DEPT. ADDITIONAL INFO PROVIDED BY THE FACILITY INDICATED THE NURSE FINISHED THE IV AND SET THE NEEDLE DOWN AND DURING CLEAN UP SHE RECEIVED A NEEDLESTICK IN HER FINGER. IT IS NOT KNOWN IF THE CLIP WAS ACTIVATED OVER THE NEEDLE TIP WHEN THE NURSE LAID IT DOWN. THE CLINICIAN AND THE PT RECEIVED ALL PROTOCOL HOSP BLOODWORK TESTING AND ALL TESTING RESULTS HAVE BEEN NEGATIVE. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MEDICAL, INC. NA 0I01258273

    Patients

    Seq Age Sex Outcome Treatment
    1 Other