BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER

    MDR report key: 9880372 · Received March 25, 2020

    Report

    Report Number
    1018233-2020-02110
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Report Date
    May 5, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741039041
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED. 52 ORANGE LATEX INTERMITTENT CATHETERS. ALL THE CATHETERS CONTAINED COUDE CURVES. THE REPORTED EVENT WAS NOT CONSIDERED TO BE A PRODUCT FAILURE, AS SPECIFICATIONS STATED "ACCEPT ANY CURVE UNLESS CATHETER IS COMPLETELY STRAIGHT.". A DEVICE HISTORY RECORD REVIEW WAS NOT REQUIRED PER THE INVESTIGATION. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 51 CATHETERS WERE UNUSABLE BECAUSE THE CURVED TIPS WERE TOO CURVED, WHICH MADE THEIR USE EXCRUCIATINGLY PAINFUL. NO MEDICAL INTERVENTION WAS REPORTED.

    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 51 CATHETERS WERE UNUSABLE BECAUSE THE CURVED TIPS WERE TOO CURVED, WHICH MADE THEIR USE EXCRUCIATINGLY PAINFUL. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345067 BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER COUDE CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 802514 NGDX4060 00801741039041

    Patients

    Seq Age Sex Outcome Treatment
    1