BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 2123399 · Received June 10, 2011

    Report

    Report Number
    2523676-2011-00060
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS DISCARDED AND WAS NOT MADE AVAILABLE TO THE MFR TO BE EVALUATED. WITHOUT THE ACTUAL SAMPLE A THOROUGH EVAL COULD NOT BE PERFORMED. IT HAS BEEN REPORTED THAT THE NURSE INSERTED THE CATHETER AND LAID THE STYLET DOWN. WHEN SHE WENT TO GATHER UP THE SUPPLIES TO DISPOSE OF, SHE RECEIVED A NEEDLESTICK INJURY. 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 UNKNOWN IF THE CLIP COVERED THE NEEDLE BEFORE LAYING 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 REPORTED LOT NUMBER. ALL AVAILABLE INFO HAS BEEN PROVIDED TO THE ACTUAL MFR FOR EVAL.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: NURSE (B)(6) HAD INSERTED CATHETER, LAID STYLET DOWN. WHEN SHE WENT TO GATHER UP THE SUPPLIES TO DISPOSE OF, SHE RECEIVED NEEDLESTICK INJURY TO LEFT THUMB. SAFETY CLIP WAS ON SHAFT OF STYLET. PT NOT DOCUMENTED TO HAVE A BLOOD BORN PATHOGEN. FACILITY TO FOLLOW PROTOCOL FOR NEEDLESTICK INJURY. STYLET WAS NOT SEQUESTERED. HAD BEEN DISPOSED OF IN A SHARPS CONTAINER WITH OTHER SHARPS. ON (B)(6) 2011 - ADDITIONAL INFO PROVIDED BY THE FACILITY INDICATED BOTH THE PT AND THE NURSE RECEIVED ALL PROTOCOL BLOODWORK TESTING AND THE RESULTS HAVE BEEN NEGATIVE. IT IS UNKNOWN IF THE CLIP COVERED THE NEEDLE TIP BEFORE LAYING THE NEEDLE DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MEDICAL, INC. NA 0M22258371

    Patients

    Seq Age Sex Outcome Treatment
    1 Other