BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTRAD 70

    MDR report key: 2355550 · Received December 1, 2011

    Report

    Report Number
    2122870-2011-05542
    Event Type
    Malfunction
    Date Received
    December 1, 2011
    Date of Event
    November 4, 2011
    Report Date
    November 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JCB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED PHOTOS REVEALED THAT THERE WAS NO SHIPPING DAMAGE TO THE AFFECTED BOTTLE. NO ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY OBSERVED A LEAK COMING FROM A BOTTLE OF CONTRAD 70. THE LEAK WAS OBSERVED AT A DEALER FACILITY. IT IS UNKNOWN AS TO WHETHER PERSONNEL INTERFACING WITH THE CONTRAD 70 WERE WEARING PERSONAL PROTECTIVE EQUIPMENT HOWEVER, THERE WAS NO REPORT OF ANY PERSONNEL SEEKING MEDICAL ATTENTION ASSOCIATED WITH THIS EVENT. NO PATIENT RESULTS WERE INVOLVED IN THIS EVENT. THERE WAS NO MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THERE WAS NO CHEMICAL/BIOHAZARDOUS EXPOSURE TO PERSONNEL UNCOVERED WOUNDS OR MUCOUS MEMBRANES AND NO INJURIES WERE REPORTED. THE AMOUNT OF LEAKAGE FOR THIS EVENT COULD NOT BE DETERMINED. ALTHOUGH THE FLUID VOLUME OF THE CONTRAD 70 CONTAINER IS THEORETICALLY SIGNIFICANT ENOUGH TO CAUSE A SLIPPING HAZARD IF IT IS SPILLED, THERE WERE NO REPORTS OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THERE WAS AN EXPOSURE CONTROL PLAN IN PLACE AT THE FACILITY AND THE MATERIAL DATA SAFETY SHEETS WERE REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTRAD 70 DETERGENT JCB BECKMAN COULTER, INC. NA 624224

    Patients

    Seq Age Sex Outcome Treatment
    1