MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® MINNESOTA FOUR LUMEN TUBE; ESOPHAGEAL TAMPONADE TUBE

Catalog Number	0092220
Medical Device Problem Codes	Difficult to Remove (1528); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
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: 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 that the customer stated that the incident happened to them when they put down the blakemore for few months ago.Was very difficult to pull out the stoppers, had to use a set of clamps from the procedure kit.
Event or Problem Description
It was reported that the customer stated that the incident happened to them when they put down the blakemore for few months ago.Was very difficult to pull out the stoppers, had to use a set of clamps from the procedure kit.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Complete initial reporter facility name: brightshores health system (fka grey bruce health services hospital corporation).Correction: f, 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.
Event or Problem Description
It was reported that the customer stated that the incident happened to them when they put down the blakemore for few months ago.Was very difficult to pull out the stoppers, had to use a set of clamps from the procedure kit.
Additional Manufacturer Narrative
The reported event was confirmed by capa association to be design related as per capa # 11273661, the root cause for this failure is: the difficulty to remove the plugs of the long form catheters can most likely be attributed to the provision of insufficient instructions.Consequently, users resorted to incorrect techniques, resulting in complications and delays during the plug removal process.The instructional insufficiency occurred because plug removal was not identified as a critical risk in the risk management file.A risk review and labeling review are not required because the investigation was confirmed by the capa # 11273661.A dhr review was not required because the investigation was confirmed by the capa association.A capa # 11273661 has been opened for this failure.Refer to the capa for further action.Correction: d,e.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.

• Brand Name: BARD® MINNESOTA FOUR LUMEN TUBE
• Common Device Name: ESOPHAGEAL TAMPONADE 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: 22904275
• Report Number: 1018233-2025-07106
• Device Sequence Number: 12766979
• Product Code: KNT
• UDI-Device Identifier: 00801741076824
• UDI-Public: (01)00801741076824(11)240820(17)270531(10)MCJU1617
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 10/10/2025

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: 0092220
• Device Lot Number: MCJU1617
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 08/29/2025; 10/10/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/10/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2024
• 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: Female