BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA RED RUBBER URETHRAL COUDE CATHETER, 16 FR.

    MDR report key: 6487448 · Received April 12, 2017

    Report

    Report Number
    1018233-2017-01743
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Report Date
    June 14, 2017
    Manufacturer
    C.R. BARD, INC. (MONCKS) -1030583
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD 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 BARD.

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, BARD MEDICAL HAS DETERMINED THAT THIS MDR WAS INITIALLY REPORTED IN ERROR ON A 3500A FORM. ACCORDING TO BARD MEDICAL DIVISION'S REPORTABILITY GUIDELINES, IT WAS DETERMINED THAT THIS IS A NON-REPORTABLE EVENT. THE INFORMATION PROVIDED BY BARD 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 BARD.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD 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 BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS TOO FLIMSY DURING INSERTION. THE PATIENT ALLEGES THAT THE DEVICE COULD NOT BE USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS TOO FLIMSY DURING INSERTION. THE PATIENT ALLEGES THAT THE DEVICE COULD NOT BE USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS TOO FLIMSY DURING INSERTION. THE PATIENT ALLEGES THAT THE DEVICE COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269500 BARDIA RED RUBBER URETHRAL COUDE CATHETER, 16 FR. COUDE CATHETER EZC C.R. BARD, INC. (MONCKS) -1030583 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1