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

Model Number	8888145014
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, after catheterization, the patient used it for less than 1 month, and during dialysis treatment, the blue luer adapter/head was cracked (broken tip).Iodophor was the cleaning agent used on the device.Iodophor was typically utilized to clean the adapters.Nothing unusual was observed on the device prior to use.Flushing was done prior to use, and the result was normal.Blood vessel was the other product being utilized with the device.No other defects/damages were found on the product.The tube/catheter was replaced as a medical intervention/treatment required as a result of the event to address the issue.There was no blood loss.Blood transfusion was not required.There was no reported patient injury.
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, after catheterization, the patient used it for less than 1 month, and during dialysis treatment, the blue luer adapter/head was cracked (broken tip).Iodophor was the cleaning agent used on the device.Iodophor was typically utilized to clean the adapters.Nothing unusual was observed on the device prior to use.Flushing was done prior to use, and the result was normal.The vascular access site was also utilized with the device.No other defects/damages were found on the product.The catheter was replaced as a medical intervention/treatment required as a result of the event to address the issue.The treatment was completed.There was no blood loss.Blood transfusion was not required.There was no reported patient injury.
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.

• Brand Name: PALINDROME
• 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: jon cornell ; 15 hampshire street; mansfield, MA 02048 ; 8772111850
• MDR Report Key: 23539115
• Report Number: 1282497-2025-00644
• Device Sequence Number: 13182420
• Product Code: MSD
• UDI-Device Identifier: 10884521013148
• UDI-Public: (01)10884521013148(17)260617(10)2113400070
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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: 06/17/2026
• Device Model Number: 8888145014
• Device Catalogue Number: 8888145014
• Device Lot Number: 2113400070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 11/13/2025
• 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