BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD POLYURETHANE URETERAL CATHETER-CONE TIP

    MDR report key: 2241059 · Received August 17, 2011

    Report

    Report Number
    1018233-2011-00185
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 19, 2011
    Manufacturer
    C.R. BARD, INC.
    Product Code
    EYB
    PMA / PMN Number
    PRE AM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED IN TWO SECTIONS MEASURING 31 CM AT THE DISTAL PORTION AND 38.5 CM AT THE PROXIMAL PORTION OF THE CATHETER. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MFG-RELATED CAUSE FOR THIS EVENT. QA PERFORMS 100% INSPECTION OF THE PRODUCT INTEGRITY AND LENGTH OF THE CATHETERS. THE CURRENT PROCESS CONTROLS ARE INTENDED TO DETECT THIS TYPE OF FAILURE MODE. THE DIRECTIONS FOR USE STATES IN THE CAUTION SECTION: "DO NOT WITHDRAW URETERAL CATHETER WHILE IT IS DEFLECTED IN ENDOSCOPE. AVOID SHARP BENDING." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT BROKE IN THE PT UPON REMOVAL. THE PHYSICIAN HAD TO USE GRASPERS TO RETRIEVE THE BROKEN DEVICE. THE FACILITY REPORTED THAT THERE WAS NOTHING UNUSUAL ABOUT THE CATHETER DURING EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD POLYURETHANE URETERAL CATHETER-CONE TIP EYB C.R. BARD, INC. NA REVA0431

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK