BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ROUND DRAIN

    MDR report key: 25196442 · Received May 17, 2026

    Report

    Report Number
    1018233-2026-03254
    Event Type
    Malfunction
    Date Received
    May 17, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 15, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    GBX
    UDI-DI
    00801741049439
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 SPD DEPARTMENT FOUND, UPON PULLING CASES, THAT A FEW OF THE TUBES HAD BLACK DOTS ON THEM (NOT ALL PACKAGES). ADDITIONAL PRODUCTS UNDER ANOTHER REFERENCE NUMBER WERE ALSO NOTED TO HAVE BLACK DOTS ALONG THE TUBING. IT WAS FURTHER REPORTED THAT BOTH REF 070210AND 070310 HAD THESE BLACK DOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8074 SILICONE ROUND DRAIN ROUND DRAIN GBX C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741049439

    Patients

    Seq Age Sex Outcome Treatment
    1