BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVARRE UNIVERSAL DRAIN

    MDR report key: 18343356 · Received December 18, 2023

    Report

    Report Number
    3006260740-2023-05749
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    May 17, 2023
    Report Date
    February 20, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    GBX
    UDI-DI
    00801741037009
    PMA / PMN Number
    K951475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO REPORT THAT MFR RPT# 3006260740-2023-05749 WAS A DUPLICATE RECORD AND WAS OPENED IN ERROR. THE EVENT DETAILS ARE BEING CAPTURED UNDER COMPLAINT FILE #8090613 AND WAS REPORTED TO THE FDA UNDER MFR RPT# 3006260740-2023-02625. H10: D4 (EXPIRY DATE: 10/2025), G3 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 : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. H10: D4 (EXPIRY DATE: 10/2025). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOMETIMES POST ASCITES DRAINAGE CATHETER PLACEMENT, THE CATHETER INTERFACE WAS ALLEGEDLY FOUND BE DEHISCENCE. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOMETIMES POST ASCITES DRAINAGE CATHETER PLACEMENT, THE CATHETER INTERFACE WAS ALLEGEDLY FOUND BE DEHISCENCE. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2298353 NAVARRE UNIVERSAL DRAIN CHRONIC CATHETERS GBX C.R. BARD, INC. (BASD) -3006260740 GFGW2081 00801741037009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown