BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREWICK FEMALE EXTERNAL

    MDR report key: 8594651 · Received May 9, 2019

    Report

    Report Number
    1018233-2019-02393
    Event Type
    Injury
    Date Received
    May 9, 2019
    Report Date
    June 27, 2019
    Manufacturer
    PUREWICK CORPORATION ¿ 3012224959
    Product Code
    NZU
    UDI-DI
    00801741151781
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE COULD BE " A LEAK IN Y-TUBING WITH FLUID INGRESS" LEADING TO A POTENTIAL FAILURE MODE THAT "PUMP DOES NOT PROVIDE ADEQUATE VACUUM LEADING TOO LITTLE TO NO SUCTION". 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: "¿ CHECK TUBING CONNECTIONS. SECURE ENDS OF VACUUM TUBING AND CONFIRM THAT (SHORTER) VACUUM TUBING IS CONNECTED FROM VACUUM PORT IN CENTER OF COLLECTION CANISTER LID TO DRYDOC¿ VACUUM STATION. CONFIRM THAT THE PATIENT TUBING IS FIRMLY CONNECTED FROM PUREWICK¿ FEC TO PATIENT PORT NEAR EDGE OF COLLECTION CANISTER LID. ¿ CHECK PATIENT TUBING FOR BLOCKAGE OR FLOW RESTRICTION SUCH AS PINCHED OR KINKED TUBING ¿ CHECK DRYDOC¿ VACUUM STATION. WITH BOTH TUBES ATTACHED TO COLLECTION CANISTER LID, TURN ON DRYDOC¿ VACUUM STATION. IF A PUREWICK¿ FEC IS ATTACHED TO THE END OF THE PATIENT TUBING, REMOVE THE PUREWICK¿ FEC AND HOLD END OF TUBING IN A CUP OF WATER. THE SYSTEM SHOULD EASILY VACUUM WATER INTO COLLECTION CANISTER. IF NOT, CHECK COLLECTION CANISTER LID TO BE CERTAIN IT IS SEALED. ¿ IF WATER EASILY FLOWS INTO COLLECTION CANISTER AND THE PATIENT TUBING IS NOT BLOCKED, REPLACE CURRENT PUREWICK¿ FEC AND CAREFULLY REPOSITION PUREWICK¿ FEC AS DESCRIBED ON PAGE 8 ¿PUREWICK¿ FEMALE EXTERNAL CATHETER (FEC) INSTRUCTIONS FOR USE.¿ ¿ MAKE SURE BARRIER CREAMS AREN¿T USED WHILE USING THE PUREWICK¿ FEC. BARRIER CREAMS MAY IMPEDE SUCTION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUREWICK DRYDOC STATION WAS NOT PROVIDING SUCTION DUE TO THE DEVICE SHUTTING OFF DURING THE NIGHT. THE PATIENT DEVELOPED A URINARY TRACT INFECTION AND WAS TREATED WITH AN ANTIBIOTIC.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUREWICK DRYDOC STATION WAS NOT PROVIDING SUCTION DUE TO THE DEVICE SHUTTING OFF DURING THE NIGHT. THE PATIENT DEVELOPED A URINARY TRACT INFECTION AND WAS TREATED WITH AN ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390044 PUREWICK FEMALE EXTERNAL PUREWICK DRYDOC STATION NZU PUREWICK CORPORATION ¿ 3012224959 NA 00801741151781

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention