MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® BLAKEMORE ESOPHAGEAL-NASOGASTRIC TUBE

Catalog Number	0092110
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.The reported event is addressed within the labeling as it states: warning: on tube, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause balloon to burst.Equipment needed.1.A tube for the control of bleeding esophageal varices with balloons attached.2.Mercury manometer or aneroid gauge type of sphygmomanometer to be connected with a ¿y¿ glass tube to upper sausage balloon.8.2 to one half feet good grade rubber tubing (size and quality used on blood pressure manometer).Instructions for passing the tube.1.The tube and balloons should be well lubricated.6.Caution: it is wise to check the position of the stomach balloon in relation to the diaphragm one half hour to an hour after the tube has been introduced.Often times it will be found that the diaphragm has relaxed from spasm and the stomach balloon is no longer in gentle pressure contact with the diaphragm.This can be easily corrected by gently pulling upon the tube until the stomach balloon is again just snug against the diaphragm in its relaxed position.The balloon is finally fixed at this point.It is best to leave the esophageal balloon connected with the mercury manometer so that it may be checked every hour by the nurse in charge.The dhr review could not be performed without a lot number.No additional actions can be taken at this time.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.

• Brand Name: BARD® BLAKEMORE ESOPHAGEAL-NASOGASTRIC TUBE
• Common Device Name: NASOGASTRIC TUBE
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 24058143
• Report Number: 1018233-2026-00094
• Device Sequence Number: 21296141
• Product Code: KNT
• UDI-Device Identifier: 00801741076817
• UDI-Public: (01)00801741076817
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0092110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown