BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD BILEVEL (UNIVERSAL) FOLEY CATHETERIZATION PROCEDURE TRAY WITHOUT

    MDR report key: 6510892 · Received April 21, 2017

    Report

    Report Number
    1018233-2017-01955
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Report Date
    June 6, 2017
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
    Product Code
    KNX
    UDI-DI
    00801741029639
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HOME HEALTH AIDE

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ONE OPENED FOLEY CATHETERIZATION TRAY WITH THE ORIGINAL UNIT PACKAGING. THE REPORTED EVENT WAS CONFIRMED WITH AN UNKNOWN CAUSE. THE SYRINGE WAS RECEIVED EMPTY AND WITHOUT THE GREY CAP. THE BARREL WAS INSPECTED FOR CRACKS AND WAS NOT NOTED TO HAVE ANY DEFECT IN THE BARREL WHICH CAUSED LEAKAGE OF WATER. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "CONTENTS: URO-PREP¿ TRAY WITH: UNDERPAD, DRAPE POVIDONE-IODINE SOLUTION NPN 02076144 30CC SYRINGE (PREFILLED WITH STERILE WATER) TO INFLATE FOLEY CATHETER ONLY. DIRECTIONS FOR USE: VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE." (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE WAS ONLY HALF FULL WITH LIQUID. THE CAP WAS ALLEGEDLY ON THE DEVICE WHEN THE TRAY WAS OPENED. NO PATIENT INVOLVEMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE WAS ONLY HALF FULL WITH LIQUID. THE CAP WAS ALLEGEDLY ON THE DEVICE WHEN THE TRAY WAS OPENED. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291847 BARD BILEVEL (UNIVERSAL) FOLEY CATHETERIZATION PROCEDURE TRAY WITHOUT CATHETER TRAY KNX PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 NGAY2571 00801741029639

    Patients

    Seq Age Sex Outcome Treatment
    1