BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER

    MDR report key: 3922064 · Received June 2, 2014

    Report

    Report Number
    1018233-2014-00137
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    April 28, 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
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED. A DEVICE HISTORY RECORD WAS REVIEWED 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. DURING VISUAL EVALUATION, A CUFF ROLL WAS NOT OBSERVED. THE CATHETER WAS INFLATED WITH 10 CC OF A MIX OF BLUE METHYLENE AND TAP WATER USING A SYRINGE AND DEFLATED BY ITS OWN. AFTER DEFLATION CUFF ROLL WAS FORMED. DIMENSIONAL EVALUATION REVEALED THAT THE CATHETER WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO DEFLATE. UPON REMOVAL IT WAS OBSERVED THAT THE INFLATION ARM/LUMEN APPEARED TO BE COLLAPSED. UPON RECEIPT OF SAMPLE, BALLOON CUFF/MUSHROOM NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322139 BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER EZL PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGXJ0052

    Patients

    Seq Age Sex Outcome Treatment
    1