BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UKNOWN NASOGASTRIC TUBE

    MDR report key: 24464051 · Received February 26, 2026

    Report

    Report Number
    1018233-2026-01298
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    February 19, 2026
    Report Date
    April 17, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    BSS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT CATALOG NUMBER AND THE LOT NUMBER FOR THIS DEVICE ARE UNKNOWN. THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTION: D THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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 CUSTOMER HAD REACHED OUT REGARDING THE USE OF THE BLAKEMORE DEVICE IN THEIR GI LAB. THE CUSTOMER STATED THAT THEY WERE AWARE OF THE RECALL AND THE UPDATED GUIDELINES FOR REMOVING THE CAPS AND HAD REVIEWED THEM MULTIPLE TIMES. HOWEVER, THEY REPORTED THAT THE INSTRUCTIONS DID NOT WORK IN PRACTICE. ACCORDING TO THE CUSTOMER, IT HAD TAKEN FOUR NURSES AND TWO PAIRS OF HEMOSTATS TO REMOVE THE CAPS. THEY EXPRESSED CONCERN THAT THIS WAS HIGHLY UNHELPFUL FOR A LIFESAVING DEVICE SUCH AS THE BLAKEMORE AND ASKED WHETHER ALTERNATIVE OPTIONS WERE AVAILABLE. THE CUSTOMER QUESTIONED WHETHER THE DEVICE REQUIRED CAPS AT ALL, NOTING THAT WHEN THE PRODUCT WAS USED, THE PATIENT WAS TYPICALLY IN CRITICAL CONDITION AND THE DEVICE NEEDED TO BE OPERATIONAL AS QUICKLY AS POSSIBLE. THEY STATED THAT IDEALLY, STAFF SHOULD BE ABLE TO OPEN THE BOX AND BEGIN USE IMMEDIATELY. THE CUSTOMER ACKNOWLEDGED THAT THEY MIGHT BE UNAWARE OF CERTAIN MANUFACTURING REGULATIONS BUT REACHED OUT IN HOPES OF IMPROVING THE PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD REACHED OUT REGARDING THE USE OF THE BLAKEMORE DEVICE IN THEIR GI LAB. THE CUSTOMER STATED THAT THEY WERE AWARE OF THE RECALL AND THE UPDATED GUIDELINES FOR REMOVING THE CAPS AND HAD REVIEWED THEM MULTIPLE TIMES. HOWEVER, THEY REPORTED THAT THE INSTRUCTIONS DID NOT WORK IN PRACTICE. ACCORDING TO THE CUSTOMER, IT HAD TAKEN FOUR NURSES AND TWO PAIRS OF HEMOSTATS TO REMOVE THE CAPS. THEY EXPRESSED CONCERN THAT THIS WAS HIGHLY UNHELPFUL FOR A LIFESAVING DEVICE SUCH AS THE BLAKEMORE AND ASKED WHETHER ALTERNATIVE OPTIONS WERE AVAILABLE. THE CUSTOMER QUESTIONED WHETHER THE DEVICE REQUIRED CAPS AT ALL, NOTING THAT WHEN THE PRODUCT WAS USED, THE PATIENT WAS TYPICALLY IN CRITICAL CONDITION AND THE DEVICE NEEDED TO BE OPERATIONAL AS QUICKLY AS POSSIBLE. THEY STATED THAT IDEALLY, STAFF SHOULD BE ABLE TO OPEN THE BOX AND BEGIN USE IMMEDIATELY. THE CUSTOMER ACKNOWLEDGED THAT THEY MIGHT BE UNAWARE OF CERTAIN MANUFACTURING REGULATIONS BUT REACHED OUT IN HOPES OF IMPROVING THE PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362763 UKNOWN NASOGASTRIC TUBE NASOGASTRIC TUBE BSS C.R. BARD INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1