BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® FOLEY CATHETERIZATION TRAY URO-PREP¿ TRAY

    MDR report key: 10048723 · Received May 12, 2020

    Report

    Report Number
    1018233-2020-03151
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Report Date
    June 15, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KNX
    UDI-DI
    00801741029622
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED. IT WAS UNKNOWN WHETHER THE DEVICE MET SPECIFICATIONS SINCE THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. A POTENTIAL FAILURE MODE COULD BE ¿COMPONENTS / MISSING ACCESSORIES¿ WITH A POTENTIAL ROOT CAUSE OF ¿INCORRECT OPERATION¿. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. 1. OPEN CSR WRAP TO FORM STERILE FIELD. 2. PLACE UNDERPAD BENEATH PATIENT, PLASTIC SIDE DOWN. 3. PUT ON CUFFED GLOVES. 4. POSITION DRAPE ON PATIENT. 5. REMOVE TOP TRAY. 6. OPEN LUBRICANT. LUBRICATE CATHETER. 7. POUR CLEANSING SOLUTION ONTO PREP BALLS. 8. PREP PATIENT WITH SATURATED PREP BALLS. 9. PROCEED WITH CATHETERIZATION IN USUAL MANNER. 10. IF SPECIMEN IS REQUIRED, FILL STERILE CONTAINER FROM CATHETER. 11. TOP TRAY MAY BE PLACED ON BASIN TO HELP PREVENT SPILLAGE. 12. IF URINE IS PLACED IN SPECIMEN JAR: A. SECURE CAP. B. LABEL SPECIMEN JAR. C. SEND SPECIMEN TO LABORATORY. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. BARD AND URO-PREP ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. VOLUME ON COLLECTION CONTAINER HAS BEEN CALIBRATED WITHOUT URO-PREP TRAY IN PLACE. RELEASED" H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE POVIDONE IODINE WAS MISSING FROM 4 TRAYS.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POVIDONE IODINE WAS MISSING FROM 4 TRAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510027 BARD® FOLEY CATHETERIZATION TRAY URO-PREP¿ TRAY PREP TRAY KNX C.R. BARD, INC. (COVINGTON) -1018233 782100 NGCT0688 00801741029622

    Patients

    Seq Age Sex Outcome Treatment
    1