BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSED WOUND SUCTION

    MDR report key: 22840519 · Received August 19, 2025

    Report

    Report Number
    1018233-2025-06868
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    August 13, 2025
    Report Date
    April 15, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    GCY
    UDI-DI
    00801741050022
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 UNCONFIRMED. RECEIVED 1 HUBLESS SILICONE FLAT DRAIN IN OPENED PACKAGING. VERIFIED MATERIAL NUMBER 0072430 AND BATCH NUMBER NGJX2125. VISUAL INSPECTION NOTED NO OBVIOUS OBSERVATIONS. USING THE IN-HOUSE BULB EVACUATOR THE FLAT DRAINED SUCTION METHYLENE BLUE SOLUTION (3 DROPS 1PERCENT METHYLENE BLUE PER 100ML DISTILLED WATER) SOLUTION WITHOUT DIFFICULTY. THE REPORTED EVENT WAS NOT ABLE TO BE REPLICATED. RISK, LABELLING, AND DHR REVIEW WAS NOT REQUIRED AS THE REPORTED EVENT WAS UNCONFIRMED. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTION: D,F,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.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED. RECEIVED 1 HUBLESS SILICONE FLAT DRAIN IN OPENED PACKAGING. VERIFIED MATERIAL NUMBER 0072430 AND BATCH NUMBER NGJX2125. VISUAL INSPECTION NOTED NO OBVIOUS OBSERVATIONS. USING THE IN-HOUSE BULB EVACUATOR THE FLAT DRAINED SUCTION METHYLENE BLUE SOLUTION (3 DROPS 1% METHYLENE BLUE PER 100ML DISTILLED WATER) SOLUTION WITHOUT DIFFICULTY. THE REPORTED EVENT WAS NOT ABLE TO BE REPLICATED. RISK, LABELLING, AND DHR REVIEW WAS NOT REQUIRED AS THE REPORTED EVENT WAS UNCONFIRMED. CORRECTIONS MADE TO TAB F. 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 DEFECTIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WOUND DRAIN WAS DEFECTIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WOUND DRAIN WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252587 CLOSED WOUND SUCTION WOUND SUCTION GCY C.R. BARD INC. (COVINGTON) -1018233 NGJX2125 00801741050022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other