BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® NASOGASTRIC SUMP TUBE

    MDR report key: 22554338 · Received July 21, 2025

    Report

    Report Number
    1018233-2025-05989
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    July 16, 2025
    Report Date
    October 7, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    BSS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 INCONCLUSIVE. THE CONDITIONS OF THE SAMPLE DID NOT ALLOW FURTHER EVALUATION. VISUAL EVALUATION OF THE RETURNED ONE-PHOTO SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), USED NASOGASTRIC TUBE. VISUAL INSPECTION OF THE SAMPLE NOTED UNABLE TO CONFIRM THE CONDITION OF THE AFFECTED NASOGASTRIC TUBE TO ONLY PHOTO PROVIDED FOR INVESTIGATION. FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED IF ONLY BASED ON THE ATTACHED PHOTO. THEREFORE, THE REPORTED EVENT IS INCONCLUSIVE DUE TO POOR SAMPLE CONDITION. 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. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTION: 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.

    Description of Event or Problem · 0

    IT WAS REPORTER THAT THE CUSTOMER REPORTS LEAKING OF ITEM 0042160, LOT # NGJX2121.

    Description of Event or Problem · 0

    IT WAS REPORTER THAT THE CUSTOMER REPORTS LEAKING OF ITEM 0042160, LOT # NGJX2121.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2784784 BARD® NASOGASTRIC SUMP TUBE NASOGASTRIC TUBE BSS C.R. BARD INC. (COVINGTON) -1018233 NGJX2121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other