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

Model Number	8888145045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that there was a crack on the venous luer adapter.It was reported that the luer adapter was cracked and leaking.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur by overtightening the adapter.Overtightening the luer adapter can cause excess stress on it which can lead to cracks/breaks in the material.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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, during normal use, it was found that there was a crack on the blue (venous) intravenous adapter.It was also stated that there was a leak at the luer adapter.The catheter was not repaired, tego was not utilized.There was no instrument used to loosen or tighten the device.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: 21593783
• Report Number: 1282497-2025-00135
• Device Sequence Number: 12967390
• Product Code: MSD
• UDI-Device Identifier: 10884521017900
• UDI-Public: 10884521017900
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112477
• 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
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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: 05/16/2026
• Device Model Number: 8888145045
• Device Catalogue Number: 8888145045
• Device Lot Number: 2302500136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• 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