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

Model Number 0092220

Device Problems Difficult to Remove (1528); Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that it was impossible for the customer to remove the caps from the two ends of the minnesota tube where the valves were installed to inflate the balloons in the stomach and esophagus.Per additional information received via email on 9 january 2020 from ibc representative, the minnesota tube was used for training purposes.There was no patient involvement.

Event Description

It was reported that it was impossible for the customer to remove the caps from the two ends of the minnesota tube where the valves were installed to inflate the balloons in the stomach and esophagus.Per additional information received via email on 9 january 2020 from ibc representative, the minnesota tube was used for training purposes.There was no patient involvement.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause will be added to the design failure mode and effect analysis.A labeling review was not completed as it would be unlikely that the user would cause this issue.

• Brand Name: BARD® MINNESOTA FOUR LUMEN TUBE
• Type of Device: MINNESOTA TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9611256
• MDR Text Key: 180393418
• Report Number: 1018233-2020-00452
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741076824
• UDI-Public: (01)00801741076824
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 0092220
• Device Catalogue Number: 0092220
• Device Lot Number: MCDX2945
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/21/2020
• Supplement Dates Manufacturer Received: 03/06/2020
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1