BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER

    MDR report key: 8216817 · Received January 4, 2019

    Report

    Report Number
    1018233-2019-00095
    Event Type
    Injury
    Date Received
    January 4, 2019
    Report Date
    February 1, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741030406
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿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. DIRECTIONS FOR USE: 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. IF A STANDING COLUMN OF URINE IS OBSERVED, CHECK FOR CORRECT POSITIONING OF BAG AND THEN FOR A PHYSICAL OBSTRUCTION. IF CORRECT POSITIONING OR REMOVAL OF PHYSICAL OBSTRUCTION DOES NOT ALLOW FREE FLOW, THE BAG MAY HAVE TO BE CHANGED." PATIENT CODE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A URINARY TRACT INFECTION FOLLOWING USE OF THE CATHETER. THE TRAY WAS MANUFACTURED WITHOUT THE POVIDONE-IODINE PRE-SATURATED SWABSTICKS DUE TO A MARKET WIDE SHORTAGE. THE PATIENT ALLEGEDLY FELT THAT THE LACK OF POVIDONE-IODINE PRE-SATURATED SWABSTICKS WITHIN THE TRAY CONTRIBUTED TO THE URINARY TRACT INFECTION. THE UTI WAS REPORTEDLY TREATED WITH ANTIBIOTICS.

    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 PATIENT EXPERIENCED A URINARY TRACT INFECTION FOLLOWING USE OF THE CATHETER. THE TRAY WAS MANUFACTURED WITHOUT THE POVIDONE-IODINE PRE-SATURATED SWABSTICKS DUE TO A MARKET WIDE SHORTAGE. THE PATIENT ALLEGEDLY FELT THAT THE LACK OF POVIDONE-IODINE PRE-SATURATED SWABSTICKS WITHIN THE TRAY CONTRIBUTED TO THE URINARY TRACT INFECTION. THE UTI WAS REPORTEDLY TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10399 BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER URETHRAL CATHETER TRAY KOD C.R. BARD, INC. (COVINGTON) -1018233 772414 UNK 00801741030406

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention