BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE FLAT DRAIN

    MDR report key: 22520437 · Received July 16, 2025

    Report

    Report Number
    1018233-2025-05902
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    July 4, 2025
    Report Date
    February 20, 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 EVENT WAS CONFIRMED CAUSE UNKNOWN. RECEIVED 1 HUBLESS SILICONE FLAT DRAIN WITH PACKAGING LABEL. VERIFIED MATERIAL NUMBER 0070370 AND BATCH NUMBER NGJX2539. VISUAL INSPECTION NOTED BLACK SPECKS ON TUBING. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. PRODUCT LABELING WAS REVIEWED FOR THIS INVESTIGATION. THE REPORTED EVENT IS ADDRESSED WITHIN THE LABELING. CORRECTION: F, 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 WHEN THE WOUND DRAIN WAS OPENED IN THE OPERATION ROOM TO BE USED FOR WASTE LIQUID, A MOLDING DEFECT WAS FOUND AT THE CONNECTION BETWEEN THE BAG AND THE DRAIN, SO IT WAS DECIDED NOT TO USE IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE WOUND DRAIN WAS OPENED IN THE OPERATION ROOM TO BE USED FOR WASTE LIQUID, A MOLDING DEFECT WAS FOUND AT THE CONNECTION BETWEEN THE BAG AND THE DRAIN, SO IT WAS DECIDED NOT TO USE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162907 SILICONE FLAT DRAIN SILICONE FLAT DRAIN GBX C.R. BARD INC. (COVINGTON) -1018233 NGJX2539 00801741090745

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other