BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK FLEX FEMALE EXTERNAL CATHETER

    MDR report key: 23027185 · Received September 11, 2025

    Report

    Report Number
    1018233-2025-07895
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    September 4, 2025
    Report Date
    October 8, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    NZU
    UDI-DI
    00801741226984
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, IT HAS BEEN DETERMINED THAT THIS IS NOT REPORTABLE. SUBMITTING THE INVESTIGATION DETAILS AS ADDITIONAL INFORMATION. THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE LABELING IS FOUND TO BE ADEQUATE. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER CALLED. THE UNIT DOESN'T WORK, AND HE HAS SPENT 9 NIGHTS WITH NO SUCCESS. REP WENT THROUGH TROUBLE SHOOTING TECHS ON HOW TO PLACE THE WICK. HE SAID IT DOES SUCTION THE WATER. REP ADVISED HIM NOT TO WEDGE THE WICK AND NOT TO PUT IT TOO LOW TO WHERE SHE IS LAYING ON IT. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. USED WITH FEMALE WICKS. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. PER CUSTOMER VIA PHONE ON 16SEPT2025 IT WAS REPORTED T/S DONE BUT STILL HAVING ISSUES, PROVIDED 800-323-0914 LIBERATOR TROUBLESHOOTING M-F 9-8 AND SAT 9-3 EST FOR CONTINUED T/S.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER CALLED. THE UNIT DOESN'T WORK, AND HE HAS SPENT 9 NIGHTS WITH NO SUCCESS. REP WENT THROUGH TROUBLE SHOOTING TECHS ON HOW TO PLACE THE WICK. HE SAID IT DOES SUCTION THE WATER. REP ADVISED HIM NOT TO WEDGE THE WICK AND NOT TO PUT IT TOO LOW TO WHERE SHE IS LAYING ON IT. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. USED WITH FEMALE WICKS. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330332 PUREWICK FLEX FEMALE EXTERNAL CATHETER PUREWICK NZU C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741226984

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other