BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE FLAT DRAIN

    MDR report key: 23167097 · Received September 29, 2025

    Report

    Report Number
    1018233-2025-08645
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    September 17, 2025
    Report Date
    April 15, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    GBX
    UDI-DI
    00801741090745
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: SECTION 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 REPORTED ISSUE WAS CONFIRMED - CAUSE UNKNOWN. RECEIVED 1 HUBLESS SILICONE FLAT DRAIN IN OPENED PACKAGING. VERIFIED MATERIAL NUMBER 0070370 AND BATCH NUMBER NGKN1621. VISUAL INSPECTION NOTED WHITE SUBSTANCE ON THE TUBE. WOUND DRAIN FILLED WITH WATER AND METHYLENE BLUE SOLUTION (3 DROPS 1% METHYLENE BLUE PER 100ML DISTILLED WATER) USING IN-HOUSE DOVAL. DRAINED WITH NO DIFFICULTY. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. CORRECTIONS MADE TO TAB(S) D AND H. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION 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 A WHITE FLAKY SUBSTANCE WAS ADHERING TO THE WOUND DRAIN TUBE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A WHITE, FLAKY SUBSTANCE WAS ADHERING TO THE WOUND DRAIN TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145872 SILICONE FLAT DRAIN WOUND DRAIN GBX C.R. BARD INC. (COVINGTON) -1018233 NGKN1621 00801741090745

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other