BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL DRAIN

    MDR report key: 24383907 · Received February 18, 2026

    Report

    Report Number
    1018233-2026-00962
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    February 4, 2026
    Report Date
    May 6, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    GBX
    UDI-DI
    00801741119194
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WOUND DRAIN WAS THE V072229 15 FR ROUND WITH TROCAR. TROCAR WAS TOO DULL, WOULD NOT PIERCE THE SKIN, FEEL LIKE THEY GOING TO HURT THEMSELVES TRIED TO PUSH THAT THROUGH THE SKIN. THE TUBING WAS VERY FLIMSY WHEN PLUGGED IT INTO THE BULB, THAT WOULD KINK AT THE INSERTION SITE AND THE BULB WAS SLOWLY INFLATING ITSELF THAT WAS THE MESSAGE CAME FROM THE FLOOR TO THE PA¿S/RNFA THAT HAD PATIENTS ON THE FLOOR. WHEN CLAMPED TO THE BED TO PREVENT THAT FROM FELL OFF, FEEL THERE ARE MICRO PUNCTURES IN THAT AND WOULD NOT ALLOW THE BULB TO STAY INFLATED, PLASTIC WAS TOO FRAGILE THEY WERE ONLY CLAMPING THE TUBE TO THE BED AT THE END OF THE TUBE, NOT IN THE MIDDLE THEY TRIED CUTTING OFF THE PART THAT WAS CLAMPED AND THAT HAD NOT MADE ANY DIFFERENCE IN THE BULB SLOWLY INFLATING WITH AIR, NOT FLUID FROM THE SITE. THE FIT OF THE TUBING TO THE BULB WAS VERY LOOSE. IN THE OFFICE WHEN DRAINS ARE PULLED, SAW CLOT COME OUT AT THE END OF THE DRAIN. THEIR OFFICE HAD SEEN MORE SEROMAS SINCE THEY HAD STARTED USING THAT DRAIN. THAT WAS FROM 2 PLASTIC SURGERY OFFICES THAT USE A LOT OF DRAINS. HAD THEY OTHER COMPLAINTS ABOUT THAT DRAIN IN PARTICULAR? WAS THERE ROOM FOR CARVE OUT TO BRING BACK THE OTHER DRAIN WITH THE TROCAR- JP2233. THEY TOLD THE SURGEONS/ PA/ RNFA THAT WORK IN THESE 2 OFFICES THAT THEY WOULD FORWARD THESE CONCERNS. IF THEY PLEASE LET THEM KNOW WHAT COULD DONE TO HELP FIX THOSE ISSUES , IT WOULD BE APPRECIATED. THEY HAD NOT HEARD ANYTHING ABOUT ANY OTHER DRAINS, JUST THAT ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546925 CHANNEL DRAIN WOUND DRAIN GBX C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741119194

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other