BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    PUREWICK URINE COLLECTION SYSTEM

    MDR report key: 11942498 · Received June 4, 2021

    Report

    Report Number
    1018233-2021-03257
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 13, 2021
    Report Date
    August 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 WAS INCONCLUSIVE AS NO SAMPLE RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE DUE TO INCORRECT OR MISSING TRANSLATION. 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 WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER WAS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE LABELLING REVIEW NOT REQUIRED AS IT COULD NOT HAVE PREVENTED THE REPORTED ISSUE. CORRECTION: E, F, 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS GREEK AND REQUIRES A TRANSLATOR. ALSO STATED THAT THE INSTRUCTIONS PROVIDED WERE NOT SUFFICIENT FOR THE PATIENT TO OPERATE THE EQUIPMENT AND REQUESTING A HOME VISIT.

    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 PATIENT WAS GREEK AND REQUIRES A TRANSLATOR, ALSO STATED THE INSTRUCTIONS PROVIDED WERE NOT SUFFICIENT FOR PATIENT TO OPERATE EQUIPMENT AND REQUESTING A HOME VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839905 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