BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE FLAT DRAIN

    MDR report key: 23123078 · Received September 23, 2025

    Report

    Report Number
    1018233-2025-08472
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    September 16, 2025
    Report Date
    March 4, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    GBX
    UDI-DI
    00801741090738
    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 REPORTED EVENT WAS CONFIRMED MANUFACTURING RELATED. RECEIVED (8) PHOTO SAMPLES. THE PHOTO SAMPLE SHOWS THE SILICONE FLAT DRAIN WITH EXCESS SILICONE FLASH MATERIAL ON THE DRAIN. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED TWO OPENED (WITHOUT ORIGINAL PACKAGING), HUBLESS SILICONE FLAT DRAIN R 0070360 AND BATCH NUMBERS NGKP1722 AND NGJZ2071. VISUAL INSPECTION OF THE RETURNED SAMPLE IDENTIFIED EXCESS MATERIAL/ SILICONE FLASH ON THE SILICONE FLAT DRAIN. THE DRAIN WAS FILLED WITH WATER AND SUBSEQUENTLY WITH 10 ML OF METHYLENE BLUE SOLUTION (PREPARED AS 3 DROPS OF 1PERCENT AQUEOUS METHYLENE BLUE PER 100 ML DISTILLED WATER). NEGATIVE PRESSURE WAS APPLIED USING AN IN HOUSE SUCTION BULB. UNDER THESE CONDITIONS, THE DRAIN DEMONSTRATED NORMAL SUCTION AND DRAINAGE FUNCTIONALITY WITH NO DIFFICULTY OBSERVED. THE LABELING IS FOUND TO BE ADEQUATE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTIONS: D, E, F, H. 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON 16SEP2025, WHEN THE WOUND DRAIN PRODUCT WAS OPENED IN THE OPERATING ROOM, A BURR WAS FOUND, AND IT WAS DISCONTINUED. WHEN A PRODUCT FROM THE SAME LOT WAS OPENED, A BURR WAS ALSO FOUND, AND IT WAS DISCONTINUED FROM USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, WHEN THE WOUND DRAIN PRODUCT WAS OPENED IN THE OPERATING ROOM, A BURR WAS FOUND, AND IT WAS DISCONTINUED. WHEN A PRODUCT FROM THE SAME LOT WAS OPENED, A BURR WAS ALSO FOUND, AND IT WAS DISCONTINUED FROM USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581409 SILICONE FLAT DRAIN WOUND DRAIN GBX C.R. BARD INC. (COVINGTON) -1018233 NGJZ2071 00801741090738

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other