BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH FOLEY CATHETER, 3WAY, 30CC, 22FR

    MDR report key: 2110896 · Received March 29, 2011

    Report

    Report Number
    8040412-2011-00037
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 4, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS NOT AVAILABLE FOR EVALUATION BY MFR. THE INVESTIGATION REPORT IS INCOMPLETE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE COMPLAINT WAS RECEIVED VIA MEDWATCH. THE PT ARRIVED FROM OPERATING ROOM TO PACU WITH A FOLEY AND CONTINUOUS BLADDER IRRIGATION (CBI) INFUSING. THE FOLEY DID NOT APPEAR TO BE DRAINING, BUT THE CBI WAS INFUSING. THE PT WOKE UP AND WAS COMPLAINING ABOUT PAIN. THE PACU RN PALPATED THE ABDOMEN AND BLADDER, THE PT CONTINUED TO COMPLAIN. THE FOLEY WAS STILL NOT DRAINING AND THE CBI WAS TURNED OFF. THE UROLOGIST INSPECTED THE 3-WAY FOLEY AND NOTICED THAT THE FOLEY AND THE CBI PORTS WERE OPPOSITE (THE FOLEY AND THE IRRIGATION PORT WERE NOT DRAINING AND THE IRRIGATION PORT WAS INFUSING INTO THE BLADDER). THE UROLOGIST SWITCHED PORTS (CBI TO CBI PORT AND FOLEY TO FOLEY PORT). THE FOLEY BEGAN DRAINING IMMEDIATELY WITH PINK TINGED URINE. THE NURSING ASSESSMENT EARLIER IN THE MONTH INDICATED THAT THE FOLEY CONTINUED TO DRAIN WELL AND THERE WERE NO OTHER ISSUES WITH IT. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH FOLEY CATHETER, 3WAY, 30CC, 22FR FOLEY CATHETER KOD TELEFLEX MEDICAL NA 10GE29

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR