BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL DRAIN

    MDR report key: 22235368 · Received June 17, 2025

    Report

    Report Number
    1018233-2025-04681
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    May 22, 2025
    Report Date
    February 6, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    GBX
    UDI-DI
    00801741049835
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED FAILURE COULD NOT BE EVALUATED BECAUSE FUNCTIONAL TESTING WAS NOT POSSIBLE AND THE DEVICE HAD MET RELEVANT SPECIFICATIONS. RECEIVED (5) PHOTO SAMPLES. THE PHOTO SAMPLE WAS RETURNED AND COULD NOT BE EVALUATED FOR THE REPORTED FAILURE. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITH ORIGINAL PACKAGING), SILICONE ROUND DRAINS WITH TROCAR NEEDLE (072221 AND BATCH NUMBER NGJW3604). VISUAL INSPECTION OF THE SAMPLE NOTED THAT THE ONE-TROCAR POINT TIP, AND ALL EDGES WERE EVALUATED, AND NO BURRS, NICKS, DISTORTION OR DULLNESS OBSERVED. THE TROCARS APPEARED TO BE SHARP. THE INVESTIGATION IS INCONCLUSIVE SINCE ONLY REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THIS MEETS THE SPECIFICATION "TROCAR POINT TIP AND ALL EDGES: SHALL BE SHARP, FREE OF BURRS, NICKS AND DISTORTION, BENT POINTS ARE NOT ALLOWED." PER (B)(4). A LABELING REVIEW WAS NOT PERFORMED BECAUSE LABELLING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. CORRECTIONS: D, 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 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 DURING USE THE NEEDLE WAS NOT SHARP ENOUGH TO PULL OUT THE CATHETER PROPERLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE, THE NEEDLE WAS NOT SHARP ENOUGH TO PULL OUT THE CATHETER PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449616 CHANNEL DRAIN WOUND DRAIN GBX C.R. BARD INC. (COVINGTON) -1018233 NGJW3604 00801741049835

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other