BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PUREWICK DISPOSABLE

    MDR report key: 11966754 · Received June 9, 2021

    Report

    Report Number
    1018233-2021-03341
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 18, 2021
    Report Date
    August 30, 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. NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "MISSING INSTRUCTIONS; VENDOR/PRINTER ERROR ". 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: "PLACE THE COLLECTION CANISTER (C) IN THE PURE WICK¿ URINE COLLECTION SYSTEM BASE AND PRESS DOWN FIRMLY ON THE LID MAKING SURE THE LID IS SEALED. ATTACH THE PUMP TUBING (D) TO THE PURE WICK¿ URINE COLLECTION SYSTEM CONNECTOR PORT (F) AND THE CONNECTOR PORT (E) ON THE COLLECTION CANISTER LID. ATTACH THE COLLECTOR TUBING (G) TO THE CONNECTOR PORT (H) ON THE COLLECTION CANISTER LID. CONNECT THE OTHER END OF THE COLLECTOR TUBING SECURELY TO A PURE WICK¿ EXTERNAL CATHETER (I). [NOTE THE LETTERS CORRELATE TO A DIAGRAM WITHIN THE IFU. CAUTION: IT IS IMPORTANT THAT THE PORT CONNECTIONS BE CONNECTED CORRECTLY AND SECURELY FOR PROPER OPERATION OF THE PURE WICK¿ URINE COLLECTION SYSTEM". 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 DID NOT UNDERSTAND HOW TO USE THE PUREWICK URINE COLLECTION SYSTEM. PER FOLLOW UP VIA PHONE 10JUN2021. SPOKE WITH CUSTOMER WHO STATED THEY COULD NOT USE THE DEVICE. CUSTOMER DOESN¿T UNDERSTAND HOW TO USE IT AND WANTS SOMEONE TO COME TO THE PATIENT HOME AND SET IT UP.

    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 PATIENT DID NOT UNDERSTAND HOW TO USE THE PUREWICK URINE COLLECTION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862318 UNKNOWN PUREWICK DISPOSABLE UNKNOWN PUREWICK CATHETER NZU C.R. BARD, INC. (COVINGTON) -1018233 PW100 NA 00801741185342

    Patients

    Seq Age Sex Outcome Treatment
    1 Other