BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRICATH® FOLEY CATHETER

    MDR report key: 8663215 · Received June 3, 2019

    Report

    Report Number
    1018233-2019-02883
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    April 29, 2019
    Report Date
    July 25, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS UNCONFIRMED. THE DEVICE WAS RETURNED AND VISUALLY INSPECTED. EVALUATION FOUND NO LEAKAGE OBSERVED EVEN WHEN PRESSURE WAS APPLIED ON SAC. SAMPLE UNDERGONE 7 DAYS LEAK TEST AND NO LEAKAGE OBSERVED. THERE WAS NO LEAKAGE FROM THE VALVE. THE CATHETER WAS DISSECTED AND NO CONDITIONS FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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: ¿[CONTRAINDICATIONS] 1. METHOD FOR USE: (1) DO NOT REUSE. (2) DO NOT RESTERILIZE. (3) THIS DEVICE CONTAINS 10% POVIDONE-IODINE. FOR PATIENTS WITH PAST HISTORY OF ALLERGIC HYPERSENSITIVITY TO POVIDONE-IODINE OR IODINE, CONSIDER USING ALTERNATIVE DISINFECTANTS. (4) BE CAREFUL THAT THE CATHETER IS NOT EXPOSED TO OINTMENTS, CONTRAST MEDIUM OR OIL-BASED LUBRICANTS (INCLUDING VEGETABLE OILS SUCH AS OLIVE OIL, MINERAL OILS SUCH AS WHITE PETROLATUM AND ANIMAL OILS). [THEY MAY DAMAGE THE DEVICE AND MAY BURST BALLOON.] (5) DO NOT HOLD THE DEVICE WITH FORCEPS, ETC. AVOID CONTACT WITH ANY BLADES OR SHARP-EDGED INSTRUMENTS. [CATHETER DAMAGE MAY CAUSE BALLOON RUPTURE AND ACCIDENTAL BALLOON REMOVAL OR FAILURE TO DEFLATE OR REMOVE THE BALLOON.] 2. APPLICABLE PATIENTS (1) DO NOT USE IN PATIENTS WHO ARE OR HAVE BEEN ALLERGIC TO NATURAL RUBBER LATEX" 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 CATHETER FELL OUT OF THE PATIENT 3 DAYS AFTER THE DAY OF PLACEMENT.

    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 CATHETER FELL OUT OF THE PATIENT 3 DAYS AFTER THE DAY OF PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455026 BARDEX® LUBRICATH® FOLEY CATHETER FOLEY CATHETER (LATEX) EZC C.R. BARD, INC. (COVINGTON) -1018233 8MP107

    Patients

    Seq Age Sex Outcome Treatment
    1