BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA COUDE OLIVE TIP URETHRAL FOLEY CATHETER

    MDR report key: 10445728 · Received August 24, 2020

    Report

    Report Number
    1018233-2020-05414
    Event Type
    Malfunction
    Date Received
    August 24, 2020
    Report Date
    December 4, 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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED. AN ORANGE INTERMITTENT CATHETER WAS RETURNED WITHOUT A PACKAGING. A SHARP BUMP WAS SEEN ON THE CATHETER SHAFT. THE CATHETER WAS RETRIEVED ON 20 JULY 2020. A CRYSTAL LIKE MATERIAL WAS FOUND INSIDE THE DRAINAGE EYE. AS THE SHARP BUMP WAS FOUND FURTHER ALONG THE SHAFT, IT WAS CONFIRMED FOR THE MATERIAL IN THE DRAINAGE EYE, AND THIS COMPLAINT WAS OPENED FOR THE SHARP BUMP. A POTENTIAL ROOT CAUSE FOR "OPERATOR OR MACHINE ERROR" WAS REVIEWED. 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." 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 THE PATIENT FELT SOMETHING SHARP ON THE CATHETER DURING INSERTION AND PULLED OUT. NO MEDICAL INTERVENTION REPORTED. PER SAMPLE EVALUATION IT WAS ALSO FOUND THAT THE CATHETER HAD A SHARP BUMP ON THE CATHETER SHAFT DURING EVALUATION.

    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 FELT SOMETHING SHARP ON THE CATHETER DURING INSERTION AND PULLED OUT. NO MEDICAL INTERVENTION REPORTED. PER SAMPLE EVALUATION IT WAS ALSO FOUND THAT THE CATHETER HAD A SHARP BUMP ON THE CATHETER SHAFT DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910015 BARDIA COUDE OLIVE TIP URETHRAL FOLEY CATHETER COUDE INTERMITTENT CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 802514 NGDW3473 00801741039041

    Patients

    Seq Age Sex Outcome Treatment
    1