BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RA CATH SET: 20 X 1-1/2

    MDR report key: 3871190 · Received May 16, 2014

    Report

    Report Number
    9680794-2014-00111
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K810675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT WAS RECEIVED VIA MEDWATCH REPORT. IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED ON A (B)(6) YR/OLD FEMALE PATIENT WEIGHING (B)(6). THE PATIENT WAS NEWLY DIAGNOSED DIABETIC; DIABETIC KETOACIDOSIS, ANEMIA, PANCREATITIS, ACUTE RENAL FAILURE VERSUS ACUTE OR CHRONIC KIDNEY DISEASE, AND MILD HYPERNATREMIA. THE REPORT STATES: INSERTED ARTERIAL LINE INTO RADIAL ARTERY. GOT BLOOD FLASH BACK. INSERTED GUIDE WIRE AND ADVANCED SHEATH. FELT RESISTANCE, RETRACTED. AFTER RETRACTED A LUMP WAS NOTED UNDER THE SKIN. CATHETER HAD HALF OF SHEATH MISSING. HALF OF SHEATH REMAINED UNDER THE SKIN. SURGEON WAS NOTIFIED. ON (B)(6) 2014, THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND UNDER FLUOROSCOPIC VISUALIZATION, MULTIPLANAR VIEWS OF THE RIGHT WRIST FOREIGN BODY WERE TAKEN WITH C-ARM FLUOROSCOPY. THE FOREIGN BODY WAS MARKED WITH METALLIC OBJECT FOR FINDING. AN INCISION WAS MADE OVER THE FOREIGN BODY. ELECTROCAUTERY WAS USED TO CUT DOWN THROUGH THE SUBCUTANEOUS TISSUE. THE FOREIGN BODY, WHICH REPRESENTED A DISTORTED MANGLED LARGE REMNANT FRAGMENT OF ANGIOCATHETER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293954 RA CATH SET: 20 X 1-1/2 ARTERIAL CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC. CF1022794

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention