BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL DRAIN

    MDR report key: 24719024 · Received March 30, 2026

    Report

    Report Number
    1018233-2026-02084
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 25, 2026
    Report Date
    May 14, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    GBX
    UDI-DI
    00801741049873
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: 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

    OUR TEAM CONDUCTED A REVIEW OF THE REPORTED EVENT, WITH THE AVAILABLE INFORMATION TO ENSURE THE ONGOING SAFETY AND PERFORMANCE OF THE PRODUCT. AS THIS INVESTIGATION HAS ALREADY BEEN PERFORMED FOR A SIMILAR COMPLAINT, ANOTHER INVESTIGATION IS NOT NECESSARY. AN INVESTIGATION HAS BEEN COMPLETED USING ALL INFORMATION CURRENTLY AVAILABLE. IT REPRESENTS A KNOWN FAILURE MODE THAT HAS BEEN ASSESSED IN THE PRODUCT RISK MANAGEMENT FILE IN ACCORDANCE WITH APPLICABLE REGULATORY STANDARDS AND INTERNAL PROCEDURES. THE ASSOCIATED RISKS CONTINUE TO BE MONITORED AS PART OF ONGOING POST-MARKET ACTIVITIES IN COMPLIANCE WITH BOTH REGULATORY REQUIREMENTS AND LOCAL PROCEDURES. CORRECTIONS MADE TO TAB(S) F AND 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 THE CUSTOMER RECENTLY CONVERTED OUR BLAKE DRAINS TO THE BD 072227 AND 072229 DRAINS. CUSTOMER WAS RECEIVING SOME COMPLAINTS ON THE BD DRAINS, PRIMARILY ON THE SIZE OF THE TROCAR COMPARED TO THE BLAKE DRAINS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER RECENTLY CONVERTED OUR BLAKE DRAINS TO THE BD 072227 AND 072229 DRAINS. CUSTOMER WAS RECEIVING SOME COMPLAINTS ON THE BD DRAINS, PRIMARILY ON THE SIZE OF THE TROCAR COMPARED TO THE BLAKE DRAINS. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 27APR2026, IT WAS REPORTED THAT TO CLARIFY, THIS WAS NOT AN ISSUE WITH A SPECIFIC LOT. OUR OR SAID THE TROCAR THAT COMES IN THE 10FR AND 15FR BLAKE DRAINS FROM BD IS TOO SMALL. THEY WANT A LARGER TROCAR SIMILAR TO THE BLAKE BRANDED DRAINS. I AM TRYING TO SEE IF BD OFFERS A PRODUCT THAT WILL MEET THEIR NEEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330602 CHANNEL DRAIN WOUND DRAIN GBX C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741049873

    Patients

    Seq Age Sex Outcome Treatment
    1