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

Model Number	8888145014P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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, when preparing for dialysis before connection, it was found that the catheter had a crack in the blue (ve nous) luer adapter/joint, and the attending physician was notified.It was also stated that it had a leak at the luer adapter.The crack was also observed prior to use.Flushing was done, and leakage occurred.There was no instrument used to loosen or tighten the device.The cleaning agent used on the device was iodophor, and it was typically utilized to clean the adapters.The cleaning agent was allowed to dry thoroughly prior to applying ointment(s) to the area.Tego was not utilized.There were no other products being utilized with the device.There was no excessive force used on the device.Aside from the reported issue, there were no other visible defects/damages found on the product at the time of the event.There was no intervention/treatment required as a result of the event.As a remedial action, the catheter was repaired.The connector was replaced.The kit was not used.The treatment was completed after the remedial action was done.There was no blood loss, and a blood transfusion was not required due to the event.There were no patient symptoms or complications associated with the event, and 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: 22321889
• Report Number: 1282497-2025-00437
• Device Sequence Number: 8812426
• Product Code: MSD
• UDI-Device Identifier: 10884521157972
• UDI-Public: 10884521157972
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123196
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2025

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: 8888145014P
• Device Catalogue Number: 8888145014P
• Device Lot Number: 2405800245
• 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: 06/09/2025
• Initial Report FDA Received Date: 06/24/2025
• Date Device Manufactured: 04/25/2024
• 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 Sex: Unknown