BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL DRAIN

    MDR report key: 21504510 · Received March 3, 2025

    Report

    Report Number
    1018233-2025-01413
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 11, 2025
    Report Date
    April 23, 2025
    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
    NE, 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.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS REPORTED IN ERROR AS IT WAS FOUND THAT THERE WAS NO ALLEGATION AGAINST PRODUCT. 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 THEY WERE HAVING SOME ISSUES WITH A FEW OF THEIR WOUND DRAINS THAT THEY HAD CONVERTED FROM CARDINAL TO BARD. PHYSICIANS WERE CONCERNED ABOUT THE BARD DRAIN NOT BEING TAPERED AND THEY WERE HAVING ISSUES WITH IT STAYING IN CORRECTLY. THE BARD ITEM NUMBERS THAT THEY WERE EXPERIENCING ISSUES WITH WERE: (PCN #(B)(6)).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY WERE HAVING SOME ISSUES WITH A FEW OF THEIR WOUND DRAINS THAT THEY HAD CONVERTED FROM CARDINAL TO BARD. PHYSICIANS WERE CONCERNED ABOUT THE BARD DRAIN NOT BEING TAPERED (PCN #072227, PCN #072229, PCN #072230) AND THEY WERE HAVING ISSUES WITH IT STAYING IN CORRECTLY. THE BARD ITEM NUMBERS THAT THEY WERE EXPERIENCING ISSUES WITH WERE: (PCN #072227, PCN #072229, PCN #072230).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634610 CHANNEL DRAIN WOUND DRAINAGE GBX C.R. BARD, INC. (COVINGTON) -1018233 UNK 00801741049873

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other