BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3072566 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10054
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    LJH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRIP CHAMBER #4 OF A Y-TYPE TUR/BLADDER IRRIGATION SET "IS TOO SMALL AND THE PLASTIC IS TOO HARD TO PURGE EASILY. ALSO, IT WAS REPORTED THAT IT WAS VERY DIFFICULT TO MOVE FLUID OUT OF DRIP CHAMBER IF THE CHAMBER WAS FULL. ADDITIONALLY, IT WAS STATED THAT THE CHAMBER FILLS UP WITH SALINE FLUSH FLUID AND THEN THE DRIPPING CAN'T BE SEEN, THEREFORE, THE USER CAN NOT TELL WHETHER THE FLUID IS MOVING AT ALL. THIS CONDITION OCCURRED DURING USE. A PATIENT WAS INVOLVED, BUT THERE IS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION NEEDED IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173593 ACCESS SYSTEM, IRRIGATION, UROLOGICAL LJH BAXTER HEALTHCARE - AIBONITO R12J10096

    Patients

    Seq Age Sex Outcome Treatment
    1