BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL DRAIN

    MDR report key: 24444447 · Received February 25, 2026

    Report

    Report Number
    1018233-2026-01216
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    February 17, 2026
    Report Date
    May 19, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    GBX
    UDI-DI
    00801741049842
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER COMPLETE FACILITY NAME: (B)(6). 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 EVENT WAS CONFIRMED - CAUSE UNKNOWN. RECEIVED 1 CHANNEL DRAIN WITH TROCAR IN OPENED PACKAGING. THIS SAMPLE WILL BE TESTED FOR "FLAKING". VERIFIED MATERIAL NUMBER 072223 AND BATCH NUMBER NGKX2316. VISUAL INSPECTION NOTED FLAKING ON THE WHITE PART OF THE CHANNEL DRAIN. FURTHER INSPECTION UNDER MICROSCOPE NOTED MULTIPLE FLAKES ON AND AROUND THE WHITE PART OF THE CHANNEL DRAIN. 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 THE 3 MORE WOUND DRAIN THAT A DOCTOR HAD USED WERE FLAKING. LOT: NGKW1644.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 3 MORE WOUND DRAIN THAT A DOCTOR HAD USED WERE FLAKING. LOT: NGKW1644, NGKX2316.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383009 CHANNEL DRAIN WOUND DRAIN GBX C.R. BARD INC. (COVINGTON) -1018233 NGKX2316 00801741049842

    Patients

    Seq Age Sex Outcome Treatment
    1