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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
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 they were asked to pull all of this esophageal tamponade tube and checked to see if the connecters were stuck or crumbling.The connectors on this one were stuck in tightly and they could not remove any of them.Per follow up via email on 07-feb-2025, the inventory controller stated as far as she knew, the device was not used on a patient.Confirmed device was material#: 0092220 and provided lot#: mcjn2679 and lot#: mcjr1392.Both devices have white plugs that cannot be removed.Per follow up email received on 19-feb-2025, the inventory controller reported that she ordered new minnesota tube devices lot#: mcjq1715 and they are also coming in with the plugs stuck and cannot be removed.She additionally confirmed the devices have not been used on any patients.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.This specific complaint allegation was part of a broader investigation captured in capa: 11273661.Visual evaluation of the returned sample noted one opened (without original packaging), minnesota four lumen tube.Visual inspection of the sample noted that the plastic plugs were unable to be separated from the balloon inflation lumens and vent tubes.Using a hemostat, the plastic plugs were able to be removed by inserting one hemostat jaw between the plug and rubber of each lumen and vent.While inserted the jaw was rotated around the plug circumference, and the plugs were able to be removed once the separation from the rubber was created.No actions can be taken at this time since a root cause was not identified.A dhr review was performed and no non-nonconformance's were found.The instructions for use were found adequate and states the following: warning: do not use lubricants containing mineral oil or petrolatum as they are harmful to rubber.Storage: store tube at room temperature away from direct exposure to light, preferably in the original packaging.Sterilization: if desired, the tube may be sterilized by ethylene oxide or steam autoclave.Exposure times will vary depending on the type of equipment used.The equipment manufacturer¿s recommendations should be followed along with the proper use of biological controls.Precaution: this is a single use device.Do not re-sterilize a portion of this device after initial sterilization and/or use.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failures, and/or lead to injury, illness or death of the patient.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 they were asked to pull all of this esophageal tamponade tube and checked to see if the connecters were stuck or crumbling.The connectors on this one were stuck in tightly and they could not remove any of them.Per follow up via email on 07-feb-2025, the inventory controller stated as far as she knew, the device was not used on a patient.Confirmed device was material#: 0092220 and provided lot#: mcjn2679 and lot#: mcjr1392.Both devices have white plugs that cannot be removed.Per follow up email received on 19-feb-2025, the inventory controller reported that she ordered new minnesota tube devices lot#: mcjq1715 and they are also coming in with the plugs stuck and cannot be removed.She additionally confirmed the devices have not been used on any patients.
Additional Manufacturer Narrative
The reported event was confirmed due to inadequate labeling.Visual evaluation of the returned sample noted one opened (without original packaging), minnesota four lumen tube.Inspection of the sample noted there was resistance during plug removal.Hemostats were used to remove the plug by inserting the jaw between the plug and the inflation lumen.All plugs were removed from the device.A dhr review was performed and no non-nonconformances were found.Product and process criteria were met for lot mcjr1392.Quality checks and lot release were performed.Product labeling was reviewed for this investigation.This specific complaint allegation was part of a broader investigation captured in capa 11273661 (medical device correction, ucc-25-5238-fa; res# 96455).Correction: 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 they were asked to pull all of this esophageal tamponade tube and checked to see if the connecters were stuck or crumbling.The connectors on this one were stuck in tightly and they could not remove any of them.Per follow up via email on 07-feb-2025, the inventory controller stated as far as she knew, the device was not used on a patient.Confirmed device was material # 0092220 and provided lot # mcjn2679 and lot # mcjr1392.Both devices have white plugs that cannot be removed.Per follow up email received on 19-feb-2025, the inventory controller reported that she ordered new minnesota tube devices lot # mcjq1715 and they are also coming in with the plugs stuck and cannot be removed.She additionally confirmed the devices have not been used on any patients.

• 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: 21462223
• Report Number: 1018233-2025-01268
• Device Sequence Number: 15438036
• Product Code: KNT
• UDI-Device Identifier: 00801741076824
• UDI-Public: (01)00801741076824(11)220426(17)270228(10)MCJR1392
• 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: MCJR1392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 06/11/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 05/14/2025; 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• 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