BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITH'S MEDICAL

    MDR report key: 1942144 · Received December 23, 2010

    Report

    Report Number
    MW5018719
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    December 16, 2010
    Report Date
    December 21, 2010
    Manufacturer
    SMITH'S MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN THE OUTPATIENT ONCOLOGY CLINIC ON (B)(6) 2010, #22 G CATHETER IN LEFT CEPHALIC VEIN CLEANLY BROKE OFF APPROX 1 MM BEYOND THE HUB. PREVIOUS NIGHT AT HOME, PT NOTICED SCANT AMOUNT OF BLOOD AT SITE AND LOOSENED COBAN DRESSING. PT HAD SOME DISCOMFORT AT IV SITE IN THE MORNING. WHEN CATHETER FLUSHED, THE BREAK WAS NOTED WITH NO VISIBLE SIGN OF THE REMAINDER. PT SENT TO RADIOLOGY WHERE CATHETER WAS VISUALIZED IN THE SOFT TISSUE OF LEFT FOREARM. PT SENT TO GENERAL SURGEON FOR REMOVAL. SURGEON UNABLE TO LOCATE CATHETER. PACKAGE OF PRODUCT NOT SAVED, BUT GIVEN SUPPLY BELIEVE THAT LOT NUMBER IS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITH'S MEDICAL 22 GA PROTECT PLUS IV FOZ SMITH'S MEDICAL 3060 1705480

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR