BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDIA URETHRAL CATHETER

    MDR report key: 10992687 · Received December 11, 2020

    Report

    Report Number
    1018233-2020-21596
    Event Type
    Injury
    Date Received
    December 11, 2020
    Date of Event
    November 17, 2020
    Report Date
    February 9, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741018367
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE. IT WAS UNKNOWN WHETHER THE DEVICE HAD MET SPECIFICATIONS. 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: "INSTRUCTIONS FOR USE INDICATIONS FOR USE: FOR UROLOGICAL USE ONLY. STORAGE: STORE CATHETERS AT ROOM TEMPERATURE AWAY FROM DIRECT EXPOSURE TO LIGHT, PREFERABLY IN THE ORIGINAL BOX. CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS. WARNINGS: ¿ ON LATEX AND RED RUBBER CATHETERS, DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX. ¿ VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. ¿ REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO FAILURE, AND/OR TO INJURY, ILLNESS OR DEATH OF THE PATIENT. NOTE: 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. ADVERSE REACTIONS URINARY TRACT INFECTION BLEEDING FROM THE URETHRA IRRITATION OF THE URETHRA INSTRUCTIONS FOR INTERMITTENT CATHETERS: 1. WASH YOUR HANDS THOROUGHLY WITH SOAP AND WATER. 2. REMOVE CATHETER FROM THE PACK. 3. POSITION YOURSELF COMFORTABLY, CLEANING THE OPENING OF THE URETHRA AND SURROUNDING AREA. 4. GENTLY INSERT ROUNDED END OF CATHETER INTO URETHRA. 5. WHEN URINE STOPS FLOWING, REMOVE CATHETER FROM URETHRA. 6. DISPOSE OF CATHETER IN ACCORDANCE WITH LOCAL RULES AND REGULATIONS. 7. WASH YOUR HANDS." 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 PATIENT GOT A URINARY TRACT INFECTION AND WENT THE A WALK-IN CLINIC WHERE THEY PRESCRIBED ANTIBIOTICS. PATIENT STATED THE URINARY TRACT INFECTION WAS FROM USING THE CATHETERS AND LUBRICANT PACKETS. ALSO STATED THAT THE DOCTOR ¿EXPLICITLY SAID THIS WAS CATHETER RELATED.¿ PATIENT SAID DOCTOR ADVISED TO USE PRE-LUBRICATED CATHETERS.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT GOT A URINARY TRACT INFECTION AND WENT THE A WALK-IN CLINIC WHERE THEY PRESCRIBED ANTIBIOTICS. PATIENT STATED THAT THE URINARY TRACT INFECTION WAS FROM USING THE CATHETERS AND LUBRICANT PACKETS. ALSO STATED THAT THE DOCTOR ¿EXPLICITLY SAID THIS WAS CATHETER RELATED.¿ PATIENT SAID DOCTOR ADVISED THE TO USE PRE-LUBRICATED CATHETERS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455815 BARDIA URETHRAL CATHETER URETHRAL CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 802416 UNK 00801741018367

    Patients

    Seq Age Sex Outcome Treatment
    1 Other