BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSED WOUND SUCTION

    MDR report key: 21547567 · Received March 7, 2025

    Report

    Report Number
    1018233-2025-01532
    Event Type
    Injury
    Date Received
    March 7, 2025
    Date of Event
    February 18, 2025
    Report Date
    October 13, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    GCY
    UDI-DI
    00801741049569
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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

    THE REPORTED EVENT WAS CONFIRMED CAUSE UNKNOWN. PHOTO: RECEIVED (2) PHOTO SAMPLES. ALL PHOTO SAMPLES SHOWCASE AN OVERVIEW OF A WOUND DRAIN AND TUBING. VISUAL: ATTEMPTED TO SUCTION MBS WITH THE RETURNED EVACUATOR AND DRAIN TUBING BUT NO SOLUTION WAS SUCTIONED. THE EVACUATOR WAS TESTED WITH INHOUSE TUBES, AND IT SUCTIONED THE MBS WITH NO ISSUES (UNCONFIRMED FOR THE EVACUATOR). THE RETURNED WOUND DRAIN WAS ATTACHED TO AN INHOUSE BULB EVACUATOR, AND NO SUCTION WAS ACHIEVED. FURTHER VISUAL INSPECTION NOTED TOTAL OBSTRUCTION AT THE END OF THE TUBING, THE ONE THAT CONNECTS TO THE BULB EVACUATOR AND ACCESSORIES, A PIN GAUGE WAS TRIED TO BE INSERTED BUT THE PATH WAS COMPLETELY BLOCKED. 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. CORRECTION: D, E, 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 INCIDENT REPORT WAS FILED ON HAD TO RETURN TO SURGERY FOR A HEMATOMA EVACUATION BECAUSE THE DRAIN DID NOT WORK AS IT SHOULD HAVE. THIS IS NOT THE FIRST PATIENT THAT THEY HAD THIS PROBLEM WITH. THIS COMPLAINT IS FOR PRODUCT (PCN #0070310) AND (PCN #0070740).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INCIDENT REPORT WAS FILED ON HAD TO RETURN TO SURGERY FOR A HEMATOMA EVACUATION BECAUSE THE DRAIN DID NOT WORK AS IT SHOULD HAVE. THIS IS NOT THE FIRST PATIENT THAT THEY HAD THIS PROBLEM WITH. THIS COMPLAINT IS FOR PRODUCT (PCN #(B)(6)) AND (PCN #(B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535204 CLOSED WOUND SUCTION WOUND DRAIN GCY C.R. BARD INC. (COVINGTON) -1018233 NGJX1869 00801741049569

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention