BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT SIMPLASTIC 22 CH/7.3MM/30ML

    MDR report key: 2028434 · Received February 18, 2011

    Report

    Report Number
    2028434
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT ARRIVED FROM THE OR TO PACU HAVING FOLEY WITH CONTINUOUS BLADDER IRRIGATION (CBI) INFUSING. THE FOLEY DID NOT APPEAR TO BE DRAINING, BUT CBI WAS INFUSING. THE PT AWOKE AND STARTED COMPLAINING OF PAIN. PACU RN PALPATED THE ABDOMEN AND BLADDER, THE PT PATIENT COMPLAINED. THE FOLEY WAS STILL NOT DRAINING, THE CBI WAS TURNED OFF. THE UROLOGIST INSPECTED THE 3-WAY FOLEY: FOLEY AND CBI (CONTINUOUS BLADDER IRRIGATION) PORTS WERE OPPOSITE (FOLEY IN IRRIGATION PORT AND NOT DRAINING; IRRIGATION PORT INFUSING INTO BLADDER). THE UROLOGIST SWITCHED PORTS (CBI TO CBI PORT; FOLEY TO FOLEY PORT). FOLEY BEGAN DRAINING IMMEDIATELY, PINK TINGED URINE. THE NURSING ASSESSMENT EARLIER THIS MONTH INDICATES THE FOLEY WAS CONTINUING TO DRAIN WELL, NO OTHER ISSUES WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT SIMPLASTIC 22 CH/7.3MM/30ML 3 WAY COUVELAIRE TIP BALLOON CATHETER KOD TELEFLEX MEDICAL 664130 570622 REORDER NUMBER

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR