BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    PUREWICK URINE COLLECTION SYSTEM STANDARD

    MDR report key: 11905795 · Received May 30, 2021

    Report

    Report Number
    1018233-2021-03102
    Event Type
    Malfunction
    Date Received
    May 30, 2021
    Date of Event
    May 6, 2021
    Report Date
    August 26, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NZU
    UDI-DI
    00801741185342
    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 AS NO SAMPLE RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE DUE TO MISSING INSTRUCTIONS OR VENDOR OR PRINTER ERROR. IT WAS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE LABELLING REVIEW NOT REQUIRED AS IT COULD NOT HAVE PREVENTED THE REPORTED ISSUE. CORRECTION: E, H. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUREWICK URINE COLLECTION SYSTEM WAS LEAKING WATER FROM UNDERNEATH AND THE FLOOR WAS WET WHEN THE PATIENT PICKED UP THE PUREWICK URINE COLLECTION SYSTEM TO MOVE IT. THE LIBERATOR REPRESENTATIVE EXPLAINED TO THE PATIENT ABOUT THE NORMAL CONDENSATION UNDER THE DEVICE AND THE PATIENT STATED THAT A CLEAR DESCRIPTION OF THAT SHOULD BE INCLUDED IN THE INSTRUCTION MANUAL.

    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 PUREWICK URINE COLLECTION SYSTEM WAS LEAKING WATER FROM UNDERNEATH AND THE FLOOR WAS WET WHEN THE PATIENT PICKED UP THE PUREWICK URINE COLLECTION SYSTEM TO MOVE IT. THE LIBERATOR REPRESENTATIVE EXPLAINED TO THE PATIENT ABOUT THE NORMAL CONDENSATION UNDER THE DEVICE AND THE PATIENT STATED THAT A CLEAR DESCRIPTION OF THAT SHOULD BE INCLUDED IN THE INSTRUCTION MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802343 PUREWICK URINE COLLECTION SYSTEM STANDARD PUREWICK URINE COLLECTION SYSTEM NZU C.R. BARD, INC. (COVINGTON) -1018233 PW100 BMEYPX01 00801741185342

    Patients

    Seq Age Sex Outcome Treatment
    1 Other