BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, PLEURX PLEURAL CATHETER

    MDR report key: 955490 · Received April 27, 2007

    Report

    Report Number
    1423507-2007-00045
    Event Type
    Malfunction
    Date Received
    April 27, 2007
    Date of Event
    March 28, 2007
    Report Date
    April 27, 2007
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KPM
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL FAILED DEVICE WAS RECEIVED FOR EVALUATION AND WAS DECONTAMINATED PRIOR TO EVALUATION. VISUAL EXAMINATION OF THE ENTIRE CATHETER SHOWED NO ANOMALIES PRESENT. IT WAS CONFIRMED THAT THE DEVICE HAD BEEN IMPLANTED SINCE A SUTURE LINE WAS ATTACHED TO THE DRAIN AS WELL AS BLOOD AND FLUIDS WERE ALSO FOUND. THE VALVE WAS DISASSEMBLED AND THE INTERNAL VALVE WAS FOUND TO BE INTACT AND IN THE CORRECT POSITION. HOWEVER, THERE WAS SOMETHING NOTED AT THE OPPOSITE SIDE OF THE VALVE HOUSING DURING VISUAL EXAMINATION. THE DUCKBILL VALVE WAS REMOVED FROM THE VALVE HOUSING AND THE ROUND SEALING RING WAS NOT IN PLACE. THE ROUND SEALING RING WAS FOUND CURLED UP INSIDE THE VALVE HOUSING ON THE OPPOSITE SIDE. IT APPEARS THAT THE SEALING RING WAS SOMEHOW PUSHED THROUGH THE DUCKBILL VALVE. A TEST WAS CONDUCTED TO DETERMINE IF THE SEALING RING COULD BE PUSHED THROUGH THE DUCKBILL VALVE AND IT WAS DETERMINED THAT IT COULD BE USING AN OBJECT SLIGHTLY LARGER IN DIAMETER THAN THE ACCESS DILATOR SPECIFICALLY USED FOR THIS PRODUCT. HOWEVER, BASED ON INFORMATION OBTAINED FROM THE END USER THEY REPORTED THAT NO OBJECT WAS INTRODUCED INTO THE VALVE HOUSING. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS REPORTED ISSUE. THIS APPEARS TO BE AN ISOLATED ISSUE. WE WILL CONTINUE TO MONITOR FOR OTHER SIMILAR REPORTS.

    Description of Event or Problem · 1

    THE PLEURX CATHETER WAS IMPLANTED IN 2007. THE RN WAS INSTRUCTING THE PATIENT ON HOW TO ACCESS THE CATHETER WITH A DRAINAGE BOTTLE. THE PATIENT WAS INSERTING THE ACCESS DILATOR AS INSTRUCTED INTO THE CATHETER, BUT FOR SOME REASON THE ACCESS TIP WOULD NOT GO INTO THE CATHETER EASILY. THE PATIENT FORCED THE TIP INTO THE CATHETER AND THEY WERE ABLE TO DRAIN FLUID FROM THE DEVICE. HOWEVER, WHEN THE TIP WAS REMOVED FROM THE CATHETER THEY NOTICED THE CATHETER WAS LEAKING FLUID. THE CATHETER WAS REMOVED FROM THE PATIENT ON THE THIRD DAY, AND THE PHYSICIAN WAS GOING TO PLACE A SECOND CATHETER WITHIN THE NEXT TWO DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT, PLEURX PLEURAL CATHETER KIT, PLEURX PLEURAL CATHETER KPM CARDINAL HEALTH 50-7000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention