BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® BLAKEMORE ESOPHAGEAL-NASOGASTRIC TUBE

    MDR report key: 24172264 · Received January 23, 2026

    Report

    Report Number
    1018233-2026-00264
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    January 8, 2026
    Report Date
    April 14, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    KNT
    UDI-DI
    00801741076817
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS AVAILABLE FOR EVALUATION AND FURTHER INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS. A LABELING REVIEW WAS NOT COMPLETED DUE TO A LACK OF INFORMATION. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. CORRECTIONS MADE TO TAB F. ALL AVAILABLE UDI INFORMATION IS BEING PROVIDED. 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: SECTIONS 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 ENDO HAD EXPERIENCED ISSUES WITH THE 0092110 BLAKEMORE AND STATED THEY HAD BEEN UNABLE TO REMOVE THE PLASTIC PIECES FROM THE END. AT THAT POINT, IT WAS DISCOVERED THAT A POSSIBLE CONNECTOR HAD BEEN MISSING AND THAT EDUCATION WAS NEEDED. SUBSEQUENTLY, A LIST WAS SENT INDICATING THAT THE PRODUCT HAD ACTUALLY BEEN DISCONTINUED, AND THEY HAD PROVIDED THE 0092300 AS THE REPLACEMENT TO ORDER INSTEAD. HOWEVER, IT HAD NOT YET BEEN RECEIVED, AND THE PURCHASE ORDER HAD SOMEHOW BEEN CLOSED. IT WAS UNCLEAR WHETHER THIS OCCURRED ON THIS SIDE OR THEIRS. ASSISTANCE WAS REQUESTED TO OBTAIN THE PRODUCT AND CLARIFICATION ON WHETHER CONNECTORS AND EDUCATION FOR ENDO WOULD BE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ENDO HAD EXPERIENCED ISSUES WITH THE 0092110 BLAKEMORE AND STATED THEY HAD BEEN UNABLE TO REMOVE THE PLASTIC PIECES FROM THE END. AT THAT POINT, IT WAS DISCOVERED THAT A POSSIBLE CONNECTOR HAD BEEN MISSING AND THAT EDUCATION WAS NEEDED. SUBSEQUENTLY, A LIST WAS SENT INDICATING THAT THE PRODUCT HAD ACTUALLY BEEN DISCONTINUED, AND THEY HAD PROVIDED THE 0092300 AS THE REPLACEMENT TO ORDER INSTEAD. HOWEVER, IT HAD NOT YET BEEN RECEIVED, AND THE PURCHASE ORDER HAD SOMEHOW BEEN CLOSED. IT WAS UNCLEAR WHETHER THIS OCCURRED ON THIS SIDE OR THEIRS. ASSISTANCE WAS REQUESTED TO OBTAIN THE PRODUCT AND CLARIFICATION ON WHETHER CONNECTORS AND EDUCATION FOR ENDO WOULD BE REQUIRED. PER THE ADDITIONAL INFORMATION RECEIVED ON 06JAN2026, IT WAS REPORTED THAT THEY NEEDED TO CIRCLE BACK TO THEIR ORIGINAL ISSUE, WHICH WAS ASSISTANCE WITH EDUCATION TO RESOLVE THE PROBLEM OF THE ENDS GETTING STUCK. THEY HAD BEEN TOLD THERE WAS A POTENTIAL ADAPTER THEY MIGHT HAVE BEEN MISSING. THIS WAS ALL BEFORE THEY WERE INFORMED THAT IT WAS NO LONGER BEING MADE, WHICH MADE THEM SWITCH GEARS. PER THE ADDITIONAL INFORMATION RECEIVED ON 07JAN2026, IT WAS REPORTED THAT IT WAS NOT CLEAR WHAT TYPE OF CONNECTOR IS BEING REFERENCED, BUT A LIVE CALL MIGHT CLEAR IT UP EASILY. THEY WOULD NEED HEMOSTATS TO REMOVE THE PLUGS, PER THE LETTER AND UPDATED IFU. PER FDA GUIDELINES THEY NEEDED TO ADDRESS SPECIFIC QUESTIONS IF THEY ARE OFF LABEL. THEY THOUGHT SHOULD LET THE CUSTOMER HAVE THE OPPORTUNITY TO REVIEW THE IFUS (WHICH HAVE BEEN UPDATED TO REFLECT THE PLUG REMOVAL IF YOU HAVE THE MOST RECENT VERSION). PER THE ADDITIONAL INFORMATION RECEIVED ON 07JAN2026, IT WAS REPORTED THAT THEY HAVE SEEN BELOW THE IFU FOR THE KNOWN ISSUE REGARDING PLUGS GETTING STUCK. PER THE ADDITIONAL INFORMATION RECEIVED ON 08JAN2026, IT WAS REPORTED THAT THE CUSTOMER WAS STILL HAVING SOME ISSUES WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227594 BARD® BLAKEMORE ESOPHAGEAL-NASOGASTRIC TUBE NASOGASTRIC TUBE KNT C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741076817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other