BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALE EXTERNAL CATHETER

    MDR report key: 8865545 · Received August 6, 2019

    Report

    Report Number
    1018233-2019-04513
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Report Date
    August 15, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NNX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE OF THIS FAILURE MODE COULD BE ¿· OPERATOR ERROR · VISCOMETER OOC · VISCOMETER FAILURE · MECHANICAL FAILURE." THE LOT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE PRODUCT CODE FOR THIS MALE EXTERNAL CATHETER PRODUCT IS UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. ALTHOUGH THE PRODUCT CODE IS UNKNOWN, THE MALE EXTERNAL CATHETER PRODUCT LABELING IS FOUND TO BE ADEQUATE BASED ON PAST REVIEWS. 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. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IT WAS DIFFICULT FOR THE PATIENT TO REMOVE THE MEC DUE TO THE ADHESIVE ON THE CATHETER.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DIFFICULT FOR THE PATIENT TO REMOVE THE MEC DUE TO THE ADHESIVE ON THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660124 MALE EXTERNAL CATHETER MALE EXTERNAL CATHETER NNX C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1