BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOMAT ILLUMINA

    MDR report key: 2608855 · Received June 5, 2012

    Report

    Report Number
    2608855
    Event Type
    Malfunction
    Date Received
    June 5, 2012
    Date of Event
    May 18, 2012
    Report Date
    June 5, 2012
    Manufacturer
    MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE POWER INJECTOR THAT WE USED SPRAYED CONTRAST ALL OVER THE PATIENT, PHYSICIAN, AND STAFF INVOLVED IN THE CASE. THE SYRINGE AT THE TIME WAS FILLED WITH CONTRAST AND SOME BLOOD. THE SYRINGE REF # IS 77-150269 LOT # IM079-1112. THE POWER INJECTOR ALSO WAS REPORTED TO BIO-MED TO BE LOOKED AT THAT SAME DAY. ALL STAFF WERE WEARING PROTECTIVE EQUIPMENT, GLOVES, AND EYE PROTECTION. THERE WAS NO EXPOSURE OF BLOOD/BODY FLUIDS TO ANYONE IN THE ROOM. THE STAFF AND PHYSICIAN INVOLVED IN THE CASE ARE VERY EXPERIENCED WITH THIS PROCEDURE AND EQUIPMENT. THERE WERE NO VISUAL DEFECTS TO ANY PIECE OF EQUIPMENT IN USE PRIOR TO THE EVENT AND NO INDICATIONS THAT THE DEVICE WOULD MALFUNCTION. STAFF REPORT THAT THIS HAS HAPPENED AT LEAST TWICE BEFORE. NO OTHER INFORMATION FROM THE PREVIOUS EXPERIENCES IS AVAILABLE. THERE WAS NO HARM TO THE PATIENT, STAFF, OR PHYSICIAN IN THIS CASE. PER BIOMED REVIEW: TALKED TO CATH LAB STAFF AND GOT DEFECTIVE SYRINGE, DECONTAMINATED SYRINGE AND INSPECTED. DISCOVERED DEFECTIVE THREADS ON SYRINGE THAT COULD COMPROMISE THE SECURITY OF THE LINE SET TO THE SYRINGE. UNABLE TO DETERMINE WHETHER THREADS WERE COMPROMISED DUE TO MANUFACTING DEFECT OR INCORRECT USE. VERIFIED THAT INJECTOR SET PRESSURE WAS WITH IN SPECIFIED ACCURACY.SYRINGE AND PACKAGING INVOLVED IN THIS EVENT WERE DISCARDED AND ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOMAT ILLUMINA INJECTOR, CONTRAST DXT MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS * *
    2 SYRINGE, CONTRAST INJECTION SYRINGE, CONTRAST INJECTION --- MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS * IM079-1112

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR