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

Catalog Number	0092220
Medical Device Problem Codes	Material Separation (1562); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
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 4 areas on this minnesota tube that have a plug that was stuck.The plugs cannot be removed as designed - multiple staff have tried and been unable to remove them.Since this was a product that was used only in an emergency, the inability to use it properly could very easily cause patient harm or death.
Event or Problem Description
It was reported that 4 areas on this minnesota tube that have a plug that was stuck.The plugs cannot be removed as designed - multiple staff have tried and been unable to remove them.Since this was a product that was used only in an emergency, the inability to use it properly could very easily cause patient harm or death.
Additional Manufacturer Narrative
The reported event is inconclusive, and no sample was returned for evaluation.A dhr review was performed and no non-non conformances were found.Product and process criteria were met for lot mcgp4820.Quality checks and lot release were performed.This specific complaint allegation was part of a broader investigation captured in capa 11273661.The capa investigation conducted a broader review of labeling, complaints, risk management file, raw materials, and manufacturing changes for this product.Correction: d, e, 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 4 areas on this minnesota tube that have a plug that was stuck.The plugs cannot be removed as designed - multiple staff have tried and been unable to remove them.Since this was a product that was used only in an emergency, the inability to use it properly could very easily cause patient harm or death.
Additional Manufacturer Narrative
The reported event is inconclusive, and no sample was returned for evaluation.A dhr review was performed and no non-nonconformance's were found.Product and process criteria were met for lot: mcgp4820.Quality checks and lot release were performed.This specific complaint allegation was part of a broader investigation captured in capa: 11273661 (medical device correction, ucc-25-5238-fa; res# 96455).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: 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, GA 30014 ; 7707846100
• MDR Report Key: 21291086
• Report Number: 1018233-2025-00500
• Device Sequence Number: 18471681
• Product Code: KNT
• UDI-Device Identifier: 00801741076824
• UDI-Public: (01)00801741076824(11)240205(17)261231(10)MCJN2679
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2025

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: MCJN2679
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 05/09/2025; 06/11/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 05/13/2025; 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: UCC-25-5238-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown