BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK URINE COLLECTION SYSTEM

    MDR report key: 11942559 · Received June 4, 2021

    Report

    Report Number
    1018233-2021-03258
    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
    00801741185359
    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. IT WAS UNKNOWN WHETHER THE DEVICE HAD MET SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "MISSING INSTRUCTIONS; VENDOR/PRINTER ERROR ". THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "INTENDED USERS THE PUREWICK¿ URINE COLLECTION SYSTEM IS INTENDED TO BE OPERATED BY: ¿ USER/PATIENT ¿ CAREGIVER/HEALTHCARE PROFESSIONAL ALL FUNCTIONS CAN BE SAFELY PERFORMED BY THE INDIVIDUALS ABOVE. INDICATIONS FOR USE THE PUREWICK¿ URINE COLLECTION SYSTEM IS TO BE USED WITH PUREWICK¿ EXTERNAL CATHETERS WHICH ARE INTENDED FOR NON-INVASIVE URINE OUTPUT MANAGEMENT. CONTRAINDICATIONS FOR USE DO NOT USE THE PUREWICK¿ URINE COLLECTION SYSTEM WITH PUREWICK¿ EXTERNAL CATHETERS ON INDIVIDUALS WITH URINARY RETENTION. SAFETY AND WARNINGS ALWAYS UNPLUG PUREWICK¿ URINE COLLECTION SYSTEM BEFORE CLEANING OR WHEN NOT IN USE. DO NOT IMMERSE THE PUREWICK¿ URINE COLLECTION SYSTEM IN WATER. AS WITH MOST ELECTRICAL DEVICES, ELECTRICAL PARTS IN THIS SYSTEM ARE ELECTRICALLY LIVE EVEN WHEN THE POWER IS OFF. TO REDUCE THE RISK OF ELECTRIC SHOCK, IF THE PUREWICK¿ URINE COLLECTION SYSTEM FALLS INTO WATER, UNPLUG IMMEDIATELY. DO NOT REACH INTO THE WATER TO RETRIEVE IT. WARNING: CONTAINS SMALL PARTS THAT MAY CAUSE CHOKING. KEEP OUT OF REACH OF CHILDREN. KEEP CORDS AND TUBING OUT OF THE REACH OF CHILDREN TO AVOID THE RISK OF STRANGULATION. DISCONTINUE USE IF AN ALLERGIC REACTION OCCURS. NOT RECOMMENDED FOR USERS WHO ARE EXPERIENCING SKIN IRRITATION OR SKIN BREAKDOWN IN DEVICE CONTACT AREAS. WARNING: THIS DEVICE SHOULD NOT BE USED IN OXYGEN RICH ENVIRONMENTS OR IN CONJUNCTION WITH FLAMMABLE ANESTHETICS." 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 DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT STATED THAT THE INSTRUCTION PROVIDED WERE NOT SUFFICIENT FOR THE PATIENT TO OPERATE EQUIPMENT. PATIENT WAS REQUESTING A HOME VISIT. REPRESENTATIVE DIRECTED PATIENT TO THE ONLINE VIDEO. ALSO ADVISED PATIENT THAT IT WAS ALL EXTERNAL AND THAT NOTHING ENTERS THE BODY.

    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 STATED THAT THE INSTRUCTION PROVIDED WERE NOT SUFFICIENT FOR THE PATIENT TO OPERATE EQUIPMENT. PATIENT WAS REQUESTING A HOME VISIT. REPRESENTATIVE DIRECTED PATIENT TO THE ONLINE VIDEO. ALSO ADVISED PATIENT THAT IT WAS ALL EXTERNAL AND THAT NOTHING ENTERS THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835983 PUREWICK URINE COLLECTION SYSTEM PUREWICK URINE COLLECTION SYSTEM NZU C.R. BARD, INC. (COVINGTON) -1018233 PW200 NA 00801741185359

    Patients

    Seq Age Sex Outcome Treatment
    1 Other