BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOMAT ILLUMENA

    MDR report key: 2093610 · Received April 19, 2011

    Report

    Report Number
    1518293-2011-00080
    Event Type
    Other
    Date Received
    April 19, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT A LATCH ON INJECTOR WAS HARD TO OPEN AND CLOSE. NURSE PINCHED HER FINGER WHILE TRYING TO CLOSE. CUSTOMER WOULD LIKE THE SYRINGE HOLDER EVALUATED. ON (B)(6): PRODUCT MONITORING (PM) FOLLOW UP WITH CUSTOMER WHO REPORTED THAT STAFF RN OPENED THE PRESSURE SLEEVE OF AN ILLUMENA INJECTOR SYSTEM AND CAUSED CONTAMINATED FLUID AND BLOOD TO SPLASH INTO THE FACE OF THE STAFF RN. RN AND PATIENT BLOOD SAMPLES HAVE BEEN TAKEN FOR TESTING TO RULE OUT BLOODBORNE PATHOGENS. CUSTOMER ACKNOWLEDGED PM TO FOLLOW UP IN COUPLE OF WEEKS WITH REGARDS TO TESTING INFORMATION. COVIDIEN HAS MADE MULTIPLE ATTEMPTS, INCLUDING A LETTER SENT VIA (B)(4) FOR ADDITIONAL INFORMATION WITH NO RESPONSE FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOMAT ILLUMENA ANGIOGRAPHIC POWER INJECTOR SYS DXT LIEBEL-FLARSHEIM CO. ILLUMENA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK