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)
Date of Event	07/08/2025
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, on the day of the event at 12:55 pm, the patient was undergoing hemodialysis on machine no.2.During the procedure, the machine frequently triggered air alarms.The nurse investigated and discovered a crack/hole and leak at the venous end (luer adapter) of the patient's right subclavian central venous catheter.Nothing unusual was observed on the device prior to use.There were no other products being utilized with the device.There was no excessive force used on the device.Tego was not utilized.The insertion site was not treated prior to product placement.The patient did not experience air embolism due to the event.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.The issue was promptly reported to the head nurse and department director, who confirmed that the frequent air alarms from the machine were caused by air entering through the crack in the catheter port.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.As a remedial action, the catheter was repaired by replacing the catheter port with a new one.It was stated that the department director immediately replaced the catheter port with a new one.After replacement, the machine was restarted, the patient was onboard again, and no further air alarms occurred.After the end of dialysis, the medical device adverse event report was completed immediately.There was no intervention/treatment done to the patient as a result of the event.There was no blood loss, and blood transfusion was not required.There was no reported patient injury.

• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22649143
• Report Number: 1282497-2025-00527
• Device Sequence Number: 8681654
• Product Code: MSD
• UDI-Device Identifier: 10884521013148
• UDI-Public: (01)10884521013148(17)260630(10)2407800098
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

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: 06/30/2026
• Device Model Number: 8888145014
• Device Catalogue Number: 8888145014
• Device Lot Number: 2407800098
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/29/2025
• Date Device Manufactured: 03/22/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Unknown