BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE FLAT DRAIN

    MDR report key: 23619455 · Received November 21, 2025

    Report

    Report Number
    1018233-2025-10466
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 23, 2025
    Report Date
    April 28, 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: 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 REPORTED EVENT WAS CONFIRMED - CAUSE UNKNOWN. SIX PHOTOS WERE RECEIVED FOR EVALUATION. THE SIX PHOTOS WERE ABLE TO SHOW THE WHITE FOREIGN MATERIAL PRESENT ON THE WOUND DRAIN CONFIRMING THE REPORTED ISSUE. RECEIVED 1 HUBLESS SILICONE FLAT DRAIN WITH PACKAGING LABEL. VERIFIED MATERIAL NUMBER 0070370 AND BATCH NUMBER NGKN1621. VISUAL INSPECTION NOTED FOREIGN MATERIAL ON THE FLAT DRAIN. PRODUCT LABELING WAS REVIEWED FOR THIS INVESTIGATION. CORRECTIONS MADE TO TAB(S) D, F, H. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. 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 BEFORE USE, TUBE WAS NOT USED BECAUSE WHITE FOREIGN MATTER WAS FOUND ON THE SHAFT PORTION OF THE WOUND DRAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, TUBE WAS NOT USED BECAUSE WHITE FOREIGN MATTER WAS FOUND ON THE SHAFT PORTION OF THE WOUND DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156862 SILICONE FLAT DRAIN WOUND DRAIN GBX C.R. BARD INC. (COVINGTON) -1018233 NGKN1621 00801741090745

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other