BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PURE WICK URINE COLLECTION SYSTEM

    MDR report key: 22905102 · Received August 27, 2025

    Report

    Report Number
    1018233-2025-07150
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    August 11, 2025
    Report Date
    August 26, 2025
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NZU
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS, AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THE PRODUCT CATALOG NUMBER AND THE LOT NUMBER FOR THIS DEVICE ARE UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 CUSTOMER CALLED ABOUT SO 1120014 AND IT LEAKS ASKED TO DO A TROUBLE SHOOT AND WATER TEST AND CUSTOMER CALLED PATIENT ON 3 WAYS TRYING TO DO THE WATER TEST, BUT PATIENT WAS NOT ABLE TO DO THE WATER TEST. CUSTOMER STATED WHEN THEY WERE WITH PATIENT THEY TRIED IT, AND THE TUBE HAD NO SUCTION WHEN THEY WERE HOLDING IT. INFORMED THAT IT'S NOT GOING TO SUCTION UNTIL IT DETECTS SOME TYPE OF FLUID AND EXPLAINED THAT THE WATER TEST WILL HAVE TO BE DONE OVER THE PHONE WITH A REP SO THEY CAN DETERMINE WHAT WAS THE ISSUE. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. USED WITH FEMALE WICKS. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380095 UNKNOWN PURE WICK URINE COLLECTION SYSTEM PURE WICK URINE COLLECTION SYSTEM NZU C.R. BARD, INC. (COVINGTON) -1018233 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other