BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREWICK URINE COLLECTION SYSTEM

    MDR report key: 11611996 · Received April 4, 2021

    Report

    Report Number
    1018233-2021-01870
    Event Type
    Injury
    Date Received
    April 4, 2021
    Date of Event
    March 15, 2021
    Report Date
    June 8, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NZU
    UDI-DI
    00801741185359
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED USE RELATED AS THE FAILURE TO SUCTION WAS CORRECTED VIA TROUBLESHOOTING. THE ROOT CAUSE OF THIS FAILURE IS "USER DOES NOT FOLLOW INSTRUCTIONS". THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN ALSO A DHR REVIEW IS NOT REQUIRED AS THE EVENT IS USE RELATED.. 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. IF THE PUREWICK¿ URINE COLLECTION SYSTEM IS DROPPED OR TIPPED OVER SPILLING URINE, UNPLUG THE UNIT AND CAREFULLY INSPECT FOR LOOSE OR DAMAGED PARTS BEFORE RESUMING USE. CONTACT CUSTOMER SUPPORT AT 1-888-201-1586 IF ANY DAMAGE IS OBSERVED. THE PUMP TUBING CONNECTING THE PUREWICK¿ URINE COLLECTION SYSTEM TO THE COLLECTION CANISTER MAY EXPERIENCE LIGHT CONDENSATION INSIDE THE TUBE. THIS IS NOT UNUSUAL AND DOES NOT AFFECT FUNCTION. HOWEVER, IF URINE OR WATER HAS STREAMED INTO THE PUMP, DISCONTINUE USE AND CONTACT CUSTOMER SUPPORT AT 1-888-201-1586. ALTHOUGH THE CANISTER CAN HOLD UP TO 2000CC (ML), THE URINE SHOULD BE EMPTIED REGULARLY FROM THE COLLECTION CANISTER BEFORE VOLUME REACHES 1800CC (ML). FAILURE TO EMPTY CANISTER BEFORE URINE OVERFLOW MAY CAUSE DAMAGE TO THE PUREWICK¿ URINE COLLECTION SYSTEM AND IS NOT COVERED UNDER THE WARRANTY. IT IS IMPORTANT THAT THE PORT CONNECTIONS BE CONNECTED CORRECTLY FOR PROPER OPERATION OF THE PUREWICK¿ URINE COLLECTION SYSTEM. USE OF THIS EQUIPMENT NEXT TO OR STACKED WITH OTHER EQUIPMENT SHOULD BE AVOIDED BECAUSE IT COULD RESULT IN IMPROPER OPERATION. IF SUCH USE IS NECESSARY, THIS EQUIPMENT AND THE OTHER EQUIPMENT SHOULD BE OBSERVED TO VERIFY THAT THEY ARE OPERATING NORMALLY. PORTABLE RADIO FREQUENCY (RF) COMMUNICATIONS EQUIPMENT (INCLUDING PERIPHERALS SUCH AS ANTENNA CABLES AND EXTERNAL ANTENNAS) SHOULD BE USED NO CLOSER THAN 12 INCHES (30CM) TO ANY PART OF THE PUREWICK¿ URINE COLLECTION SYSTEM, INCLUDING CABLES SPECIFIED BY THE MANUFACTURER. OTHERWISE, DEGRADATION OF THE PERFORMANCE OF THIS EQUIPMENT COULD RESULT. USE ONLY PUREWICK¿ URINE COLLECTION SYSTEM ACCESSORIES WITH THIS DEVICE. INCOMPATIBLE PARTS OR ACCESSORIES CAN RESULT IN DEGRADED PERFORMANCE AND WILL VOID THE WARRANTY. DO NOT USE ACCESSORIES PAST EXPIRATION DATE INDICATED ON PACKAGE LABELING. USE ONLY THE PUREWICK¿ URINE COLLECTION SYSTEM A/C POWER CORD WITH THE DEVICE. USE OF AN ALTERNATE CONSUMER STYLE A/C POWER ADAPTER OR AN EXTENSION CORD MAY CAUSE DAMAGE TO DEVICE AND ELECTRICAL SHOCK OR INJURY AND WILL VOID THE WARRANTY. DO NOT PLACE PUREWICK¿ URINE COLLECTION SYSTEM OR ITS CORD ACROSS WALKWAYS CREATING A TRIPPING HAZARD. FOR PW200: THE BATTERY CELLS USED IN THIS DEVICE MAY PRESENT A FIRE OR CHEMICAL HAZARD. TO MINIMIZE THE RISK OF DAMAGING THE BATTERY INSIDE THE PUREWICK¿ URINE COLLECTION SYSTEM, DO NOT USE THE DEVICE OUTSIDE THE INDICATED OPERATING TEMPERATURE RANGE OF 41°F - 104°F (5°C - 40°C). THE BATTERY IS NOT INTENDED TO BE REPLACED; REPLACEMENT COULD RESULT IN A HAZARD. TO REDUCE THE RISK OF ELECTRICAL SHOCK OR INJURY, DO NOT DISASSEMBLE THIS UNIT. NO MODIFICATION OF THIS EQUIPMENT IS ALLOWED." 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. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUREWICK URINE COLLECTION SYSTEM WAS NOT SUCTIONING PROPERLY AND THE PATIENT WAS FACING LEAKAGE ISSUE. CUSTOMER ADVISED LIBERATOR REPRESENTATIVE THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTION AND NO PRODUCT ALLEGATION WAS MENTIONED. REPRESENTATIVE WALKED CUSTOMER THROUGH TROUBLESHOOTING AND UNIT APPEARS TO WORK PROPERLY. REPRESENTATIVE ADVISED THEM TO MAKE SURE THE UNIT WAS ON THE FLOOR AND THAT THE PATIENT TUBING WAS NOT RESTRICTED, BECAUSE IF INNER GARMENTS WERE TOO TIGHT, IT COULD CAUSE THE UNIT TO NOT WORK PROPERLY. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AND MEDICAL INTERVENTION PROVIDED WAS UNKNOWN.

    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 PROPERLY AND PATIENT WAS HAVING LEAKAGE. CUSTOMER ADVISED LIBERATOR REPRESENTATIVE THAT THE PATIENT HAS A URINARY TRACT INFECTION CURRENTLY AND NO PRODUCT ALLEGATION WAS MENTIONED. REPRESENTATIVE WALKED CUSTOMER THROUGH TROUBLESHOOTING AND UNIT APPEARS TO WORK PROPERLY. REPRESENTATIVE ADVISED THEM TO MAKE SURE THE UNIT WAS ON THE FLOOR AND THAT THE PATIENT TUBING WAS NOT RESTRICTED, BECAUSE IF INNER GARMENTS OR PAJAMAS WERE TOO TIGHT, IT COULD CAUSE THE UNIT TO NOT WORK PROPERLY. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AND MEDICAL INTERVENTION PROVIDED WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509226 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