BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRICATH® FOLEY CATHETER

    MDR report key: 7314029 · Received March 5, 2018

    Report

    Report Number
    1018233-2018-00688
    Event Type
    Malfunction
    Date Received
    March 5, 2018
    Date of Event
    January 27, 2018
    Report Date
    March 23, 2018
    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
    NURSE

    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

    THE REPORTED ISSUE WAS UNCONFIRMED. THE DEVICE WAS RETURNED AND VISUALLY INSPECTED. EVALUATION OBSERVED NO LEAKAGE EVEN WHEN PRESSURE WAS APPLIED ON THE SAC. SAMPLE UNDERGONE A 7 DAY LEAK TEST AND NO LEAKAGE WAS OBSERVED. THERE WAS NO LEAKAGE FROM THE VALVE. THE CATHETER WAS DISSECTED AND NO CONDITIONS WERE 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 STATES THE FOLLOWING: ¿CONTRAINDICATIONS: METHOD FOR USE: DO NOT REUSE. DO NOT RESTERILIZE. 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.] 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.] 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 REMOVAL OR FAILURE TO DEFLATE OR REMOVE THE BALLOON.] " (B)(4). CORRECTION: DEVICE INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER FELL OUF OF THE PATIENT. IT WAS LATER REPORTED THE BALLOON WAS DEFLATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER FELL OUF OF THE PATIENT. IT WAS LATER REPORTED THE BALLOON WAS DEFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155533 BARDEX® LUBRICATH® FOLEY CATHETER FOLEY CATHETER (LATEX) EZC C.R. BARD, INC. (COVINGTON) -1018233 7DW0098

    Patients

    Seq Age Sex Outcome Treatment
    1