MAUDE Adverse Event Report: COVIDIEN LLC DIALYSIS UNKNOWN; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	DIALYSIS UNKNOWN
Medical Device Problem Codes	Material Puncture/Hole (1504); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, a rupture occurred in the y-near silicone tube segment of the venous legs of the catheter.The catheter had been newly placed in the left internal jugular vein.The use before date for the product had already passed by the time the reported event occurred.There was no reported patient outcome.
Additional Manufacturer Narrative
Additional information: b5, d1, d4(model #, catalog #), d4(lot # - removed, expiration date - removed, unique identifier (udi) # - r emoved), d8, g3, h6(removed - a2101).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, a rupture occurred in the y-near silicone tube segment of the venous legs of the catheter.The catheter had been newly placed in the left internal jugular vein.It was stated that the product should no longer be used, as it aged too quickly and then caused dangerous problems.There was no reported patient outcome.
Additional Manufacturer Narrative
Additional information: b5, e1(prefix, first name, last name, fax number, phone number), e3, g3.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, a rupture occurred in the y-near silicone tube segment of the venous legs of the catheter.The catheter had been newly placed in the left internal jugular vein.The use before date for the product had already passed by the time the reported event occurred.It was stated that the product should no longer be used, as it aged too quickly and then caused dangerous problems.There was no reported patient outcome.

• Brand Name: DIALYSIS UNKNOWN
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22936915
• Report Number: 1282497-2025-00567
• Device Sequence Number: 18668760
• Product Code: MSD
• UDI-Device Identifier: 10884521158504
• UDI-Public: (01)10884521158504(17)220131(10)1807300167
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2025

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 Expiration Date: 01/31/2022
• Device Model Number: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Device Lot Number: 1807300167
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 09/15/2025; 10/16/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/16/2025; 10/21/2025
• Date Device Manufactured: 03/17/2018
• 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
• Patient Sex: Unknown