BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK URINE COLLECTION SYSTEM

    MDR report key: 24501067 · Received March 3, 2026

    Report

    Report Number
    1018233-2026-01451
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 19, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    NZU
    UDI-DI
    00801741185359
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 PT SAID ISSUES WITH SUCTIONING - IT SEEMS AS IF THE DEVICE DOESN'T HAVE ENOUGH SUCTION-TO-SUCTION URINE OUT OF THE BAG - SHE TYPICALLY HAS TO PRESS ON THE BAG SOME TO GET URINE TO GO INTO TUBE THAN INTO CANISTER. NOTES: RECOMMENDED THAT TUBE IS DOWNWARDS GOING TOWARDS THE FEET TO HELP GRAVITY AND SUCTION. SHE ALSO MADE A COMPLAINT ABOUT PRICE SO I DID RECOMMENDED SPEAKING TO CS ABOUT DISCOUNTS OR SEEING IF IT COULD BE COVERED BY INSURANCE. GAVE CS NUMBER AND TIMES THEY WERE AVAILABLE: 800-323-0914, FOLLOW UP SCHEDULED A MONTH OUT (B)(6) 7PM. BRANDED AND OFFERED SURVEY. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. USED WITH MALE WICKS. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PT SAID ISSUES WITH SUCTIONING - IT SEEMS AS IF THE DEVICE DOESN'T HAVE ENOUGH SUCTION-TO-SUCTION URINE OUT OF THE BAG - SHE TYPICALLY HAS TO PRESS ON THE BAG SOME TO GET URINE TO GO INTO TUBE THAN INTO CANISTER. NOTES: RECOMMENDED THAT TUBE IS DOWNWARDS GOING TOWARDS THE FEET TO HELP GRAVITY AND SUCTION. SHE ALSO MADE A COMPLAINT ABOUT PRICE SO I DID RECOMMENDED SPEAKING TO CS ABOUT DISCOUNTS OR SEEING IF IT COULD BE COVERED BY INSURANCE. GAVE CS NUMBER AND TIMES THEY WERE AVAILABLE: 800-323-0914 FOLLOW UP SCHEDULED A MONTH OUT 03/23 7PM. BRANDED AND OFFERED SURVEY. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. USED WITH MALE WICKS. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484616 PUREWICK URINE COLLECTION SYSTEM URINE COLLECTION SYSTEM NZU C.R. BARD INC. (COVINGTON) -1018233 NA 00801741185359

    Patients

    Seq Age Sex Outcome Treatment
    1