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	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, on (b)(6) 2024, a long-term palindrome chronic catheter was implanted in the patient's internal jugular vein.The patient has been undergoing thrice-weekly scheduled hemodialysis since then.On the day of the event, at 07:17, the nurse performed catheter access procedures, including disinfection of the venous end, aspiration of heparin solution, and connection of a 10 ml syringe to test catheter functionality.A crack was observed at the threaded connection of the venous port.Blood aspiration was performed without any evidence of leakage.The incident was immediately reported to the physician, head nurse, and director.The cleaning agent(s) are allowed to dry thoroughly prior to applying ointment(s) to the area.No other products were being utilized with the device.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.No excessive force was used on the device.No other products are being utilized with the device.Nothing unusual was observed on the device prior to use.The intervention was a double-lumen catheter that was then connected for low-flow hemodialysis, with close monitoring of the patient and catheter throughout the procedure, which remained stable.The patient was informed that the venous port connector would be scheduled for replacement.There was no leak.Tego was not utilized.The insertion site was not treated prior to product placement.The catheter was repaired.There was no blood loss, and 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22860336
• Report Number: 1282497-2025-00558
• Device Sequence Number: 20754505
• Product Code: MSD
• UDI-Device Identifier: 10884521013148
• UDI-Public: (01)10884521013148(17)280913(10)2326900103
• 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: 2024
• 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): 08/21/2025

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 Model Number: 8888145014
• Device Catalogue Number: 8888145014
• Device Lot Number: 2326900103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/21/2025
• Date Device Manufactured: 10/13/2023
• 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