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

Model Number	8888145015
Medical Device Problem Codes	Break (1069); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
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 18:00 in the hemodialysis unit of the hospital, the responsible nurse followed the standard operating procedure to open the central venous catheter for a patient.Upon inspection, the gauze covering the exposed part of the catheter was found to be intact.When the tube was opened to draw the arterial line sealing solution, some air bubbles appeared in the syringe.During the blood draw process, a large amount of air was observed in the blood flowing out of the arterial line.The connection of the extracorporeal circulation pipeline was checked to be intact.The blood pump was immediately stopped, and the central venous catheter was checked.A rupture was found 2 cm below the y-connector of the catheter.A leak was observed at the bifurcate.The doctor was informed, and the catheter was sealed according to medical advice, with dialysis treatment being discontinued.The hospital was unable to replace the central venous catheter; the patient was informed to transfer to a higher-level hospital to replace the central venous catheter for hemodialysis treatment.The catheter was not repaired.The tego was not utilized.There was no luer adapter issue.The insertion site was not treated prior to product placement.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22128081
• Report Number: 1282497-2025-00379
• Device Sequence Number: 18252055
• Product Code: MSD
• UDI-Device Identifier: 20884521013169
• UDI-Public: 20884521013169
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

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: 8888145015
• Device Catalogue Number: 8888145015
• Device Lot Number: 2330300119
• 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: 05/16/2025
• Initial Report FDA Received Date: 06/02/2025
• Date Device Manufactured: 11/11/2023
• 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 Age: 51 YR
• Patient Sex: Unknown