BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL ARTERY PRESSURE MONITORING SET

    MDR report key: 2120274 · Received June 1, 2011

    Report

    Report Number
    1820334-2011-00273
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    April 30, 2011
    Report Date
    May 5, 2011
    Manufacturer
    COOK INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG # - UNK BUT SUSPECTED TO BE A C-PMS-300-RA. EXPIRATION - UNK AS LOT IS UNK. (B)(4) REMOVAL OF DEVICE PORTION IS NOT LABELED. (B)(4). EVENT EVALUATION: EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS CALLED TO THE BEDSIDE FOLLOWING THE PROCEDURE AS THE SITE WAS OOZING A LOT OF BLOOD - IT WAS THOUGHT IT WAS OOZING FROM ANOTHER POKE SITE BUT THEN IT STARTED SPURTING. PRESSURE WAS APPLIED, AND THEN A PRESSURE DRESSING APPLIED - THE LINE WAS DRAWING WELL AND HAD A GREAT WAVE FORM. SHORTLY AFTER, IT WAS NOTICED THERE WAS NO CATHETER ATTACHED TO THE HUB AND THE WAVE WAS LOST. ON X-RAY, THE CATHETER WAS NOTED TO BE INSIDE THE PT'S ARTERY. THE PHYSICIAN CALLED A SURGEON TO COME DO A CUTDOWN AND REMOVE THE CATHETER. RETRIEVED THE LOST PIECE OF LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL ARTERY PRESSURE MONITORING SET DQY CATHETER, PERCUTANEOUS DQY COOK INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other| R