BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK URINE COLLECTION SYSTEM

    MDR report key: 11624355 · Received April 6, 2021

    Report

    Report Number
    1018233-2021-01919
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 13, 2021
    Report Date
    August 12, 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 WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE COULD BE DUE TO AN "MISS OUT TO PUT IN THE CARTON BOX". IT WAS UNKNOWN WHETHER THE DEVICE HAD MET SPECIFICATIONS. THE PRODUCT WAS INTENDED TO BE USED FOR TREATMENT PURPOSE BUT IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. A LABELING REVIEW WAS NOT COMPLETED AS THE USER WOULD NOT LIKELY CAUSE THIS ISSUE. THE DEVICE WAS NOT RETURNED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUREWICK URINE COLLECTION SYSTEM WAS NOT SUCTIONING LAST NIGHT BUT THE PATIENT THOUGHT THE WICK WAS TOO TIGHT. ALSO STATED IT WAS WORKING AND THE PATIENT NEEDS A 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 NOT SUCTIONING LAST NIGHT BUT THE PATIENT THOUGHT THE WICK WAS TOO TIGHT. ALSO STATED IT WAS WORKING AND THE PATIENT NEEDS A MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522541 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