MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bard® Minnesota Four Lumen Tube; Minnesota Tube

Catalog Number	0092220
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	Unspecified Gastrointestinal Problem (4491); Insufficient Information (4580)
Date of Event	07/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Annex e codes e1033 and e2401 were selected as no specific patient health problems were reported.Considering the minnesota tube's intended use for temporary control of bleeding esophageal and gastric varices, these codes were assessed as the most appropriate based on the information available at the time of evaluation.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.
Event or Problem Description
It was reported by customer that the esophageal tamponade tube was unable to remove the plastic plugs so the tube could be fully assembled and immediately available for use during a life-threatening variceal hemorrhage, doing so under clean process in central processing to be wrapped and sterilized post assembly.Because this device was extremely time-intensive to assemble in an emergency, they made the decision to have it preassembled under central processing by a physician so it could be deployed without delay.Despite following the manufacturer's recall instructions, our physician spent approximately one hour trying to remove the plastic plugs without success.Frankly, they discovered this defect only by chance during our preparedness process.Had this first been encountered during an actual emergency, the device would have been unusable while a patient was actively bleeding.That represents a significant patient safety concern.2 serious injuries and 1 death have already been associated with this issue.

• Brand Name: Bard® Minnesota Four Lumen Tube
• Common Device Name: Minnesota 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 30014 ; +1(770)784-6100
• MDR Report Key: 25825240
• Report Number: 1018233-2026-04656
• Device Sequence Number: 10416992
• Product Code: KNT
• UDI-Device Identifier: 00801741076824
• UDI-Public: (01)00801741076824
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0092220
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/05/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2026
• Supplement Date Received by Manufacturer: 08/11/2026; 08/18/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 08/12/2026; 08/18/2026
• 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; Required Intervention
• Patient Sex: Unknown