BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALE EXTERNAL CATHETER

    MDR report key: 11922394 · Received June 2, 2021

    Report

    Report Number
    1018233-2021-03199
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    May 11, 2021
    Report Date
    July 13, 2021
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE. NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "INCORRECT LABELING OPERATION". THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. ALTHOUGH THE PRODUCT FAMILY WAS UNKNOWN, THE MALE EXTERNAL CATHETERS IFUS ARE 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 THE FONT ON THE INSTRUCTIONS WAS TOO SMALL AND THAT THE INSTRUCTIONS WERE NOT DETAILED ENOUGH.

    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 FONT ON THE INSTRUCTIONS WAS TOO SMALL AND THAT THE INSTRUCTIONS WERE NOT DETAILED ENOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819568 MALE EXTERNAL CATHETER MALE EXTERNAL CATHETER NNX C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other