BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE FOLEY CATHETER

    MDR report key: 3874847 · Received April 25, 2014

    Report

    Report Number
    1018233-2014-00091
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 26, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    EZL
    PMA / PMN Number
    K040504
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED, HOWEVER THE PROBLEM COULD NOT BE REPRODUCED. VISUAL EVALUATION DID NOT NOTE CUFF ROLL IN CATHETER. NO OBVIOUS VISUAL DEFECTS WERE NOTED ALONG THE CATHETER. THERE WERE NO MFG DEFICIENCIES NOTED ON THE RETURNED PRODUCT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE OF BALLOON CUFF ROLL. WHEN THE CATHETER WAS FUNCTIONALLY TESTED, THE CUFF ROLL WAS NOT FORMED DURING THE DEFLATION. DIMENSIONAL EVALUATION REVEALED THAT THE CATHETER WAS MANUFACTURED ACCORDING TO SPECIFICATION. AN ENTIRE REVIEW OF THE DEVICE HISTORY RECORDS FOR THE INVOLVED LOT ON THIS COMPLAINT SHOWED NO MFG DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE OF CUFF ROLL. A MFG REVIEW WAS CONDUCTED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DIST. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED TRAUMA AND BLEEDING DUE TO CUFFING OF THE CATHETER UPON REMOVAL. CATHETER WAS INDWELLING (TRANSURETHRAL) FOR THE DURATION OF THE OPERATIVE PROCEDURE, WHICH WAS 2 1/2 HOURS. THE CATHETER WAS INFLATED USING 10CC OF STERILE WATER PROVIDED IN THE KIT. NO SUTURES WERE USED TO ANCHOR THE CATHETER IN THE PT, NOR WAS THE PT PULLING ON OR TUGGING AT THE CATHETER; NO TRACTION WAS APPLIED TO THE CATHETER, NOR WAS IT CLAMPED OFF AT ANY TIME. NO TESTS (X-RAY, ULTRASOUND, CYTOSCOPY) WERE PERFORMED FOLLOWING THE EVENT. CATHETER BALLOON WAS DEFLATED USING A SYRINGE AND REMOVED SLOWLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250457 SILICONE FOLEY CATHETER EZL PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGXDX325

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR