BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK URINE COLLECTION SYSTEM

    MDR report key: 11982890 · Received June 11, 2021

    Report

    Report Number
    1018233-2021-03416
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 19, 2021
    Report Date
    September 27, 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 IS INCONCLUSIVE DUE TO POOR SAMPLE CONDITION. A BD PUREWICK URINE COLLECTION SYSTEM, PUMP TUBING, COLLECTOR TUBING WITHOUT THE ELBOW CONNECTOR, COLLECTION CANISTER WITH LID, AND EXTERNAL POWER CORD WERE RETURNED. THE DEVICE MET SPECIFICATIONS. THE DEVICE WAS BEING USED FOR TREATMENT PURPOSES. IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "PLEASE READ ALL OPERATING INSTRUCTIONS AND WARNINGS BEFORE THE FIRST USE OF THIS PRODUCT. NO SPECIAL SKILLS OR ADDITIONAL TRAINING IS REQUIRED." H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD 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 BARD. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS EVALUATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER NEED INSTRUCTIONS ON HOW TO USE THE PUREWICK URINE COLLECTION SYSTEM.

    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 USER NEED INSTRUCTIONS ON HOW TO USE THE PUREWICK URINE COLLECTION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878607 PUREWICK URINE COLLECTION SYSTEM PUREWICK URINE COLLECTION SYSTEM NZU C.R. BARD, INC. (COVINGTON) -1018233 PW100 NA 00801741185342

    Patients

    Seq Age Sex Outcome Treatment
    1 Other