BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER

    MDR report key: 10741670 · Received October 27, 2020

    Report

    Report Number
    1018233-2020-20470
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    October 1, 2020
    Report Date
    January 27, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741030444
    PMA / PMN Number
    K802665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE. NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE COULD BE DUE TO "INSPECTION RESULTS (MEASUREMENT, TESTING DATA) NOT VERIFIED BY IQA ASSIGNEE". THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. 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. LUBRICATE CATHETER WHICH IS PRE-ATTACHED TO COLLECTION BAG. 7. BAG AND CATHETER MAY BE PLACED IN BASIN UNTIL NEEDED. 8. PREP PATIENT WITH POVIDONE-IODINE SWABSTICKS. 9. PROCEED WITH CATHETERIZATION IN USUAL MANNER. 10. TOP TRAY MAY BE PLACED ON BASIN TO HELP PREVENT SPILLAGE. 11. PERIODIC OBSERVATIONS OF THIS SYSTEM SHOULD BE MADE TO ASSURE THAT URINE IS FLOWING FREELY. VOLUME ON COLLECTION CONTAINER HAS BEEN CALIBRATED WITHOUT URO-PREP¿ TRAY IN PLACE. BARD AND URO-PREP ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. ©2010 C. R. BARD, INC. ALL RIGHTS RESERVED. DIRECTIONS FOR TAKING SPECIMEN: AFTER CATHETER HAS BEEN INSERTED INTO THE BLADDER AND AN INITIAL FLOW OF URINE IS SEEN IN THE COLLECTION BAG: 1. CLAMP OFF CATHETER USING WHITE CLAMP. 2. INSERT PLASTIC TUBE (INSIDE BAG) INTO THE BACK OF THE SAMPLE DEVICE. 3. OPEN SAMPLE DEVICE OVER THE SAMPLE CONTAINER. 4. UNCLAMP CATHETER. 5. ALLOW DESIRED AMOUNT OF URINE TO DRAIN INTO COLLECTION CONTAINER. 6. CLAMP OFF CATHETER." 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. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLEY CATHETERS HAD CHANGED LENGTH FROM 16. PER TROUBLESHOOTING, THE MSS NOTICED THAT THERE WERE NO DESIGN CHANGED FEMALE AND PEDIATRIC LENGTHS ARE CLEARLY MARKED ON THE PACKAGING. AS PER THE FOLLOW UP VIA EMAIL ON 01OCT2020 ,THE ANOTHER PRODUCT CATALOG NUMBER RECEIVED WITH SAME ISSUE.

    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 FOLEY CATHETERS HAD CHANGED LENGTH FROM 16. PER TROUBLESHOOTING, THE MSS NOTICED THAT THERE WERE NO DESIGN CHANGED FEMALE AND PEDIATRIC LENGTHS ARE CLEARLY MARKED ON THE PACKAGING AS PER THE FOLLOW UP VIA EMAIL ON 01OCT2020 ,THE ANOTHER PRODUCT CATALOG NUMBER RECEIVED WITH SAME ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209575 BARD URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER SILICON FOLEY CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 772514 UNK 00801741030444

    Patients

    Seq Age Sex Outcome Treatment
    1 Other