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

Model Number	8888145015P
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, during dialysis treatment, it was found that the catheter had a broken blue (venous) luer adapter.It was stated that the blue (venous) luer adapter had a crack and a leak.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.There was nothing unusual observed on the device prior to use.Flushing was done prior to use, and the result was unremarkable.The catheter was not repaired, and tego was not utilized.There was no excessive force used on the device.The insertion site was treated prior to product placement.There were other products utilized with the device, the customer were using a competitor's extension lines with the catheter and a competitor's caps, and also circuits.The patient was not treated under general or local anesthesia.Octenisept was the cleaning agent used on the device in its entirety.Lavanide was in demand for ointment, which was utilized at the exit site.The wound dressing utilized was a leukomed patch, which did not include any cleaning agents or antimicrobial properties.The cleaning agents were allowed to dry completely before ointment application.The cleaning agents were allowed to dry thoroughly before the area is dressed.The patient was not responsible for catheter main tenance, cleaning, or dressing changes.The cleaning agent was not switched over the life of the catheter.Cleaning agents were not mixed.Sepsiderm was not used for cleaning catheters.There has been no recent change in the protocol for cleaning agents.The patients themselves did not use any type of cleaning agent or antibiotic on the catheters.As a remedial action, the arterial leg was used.There was no intervention/treatment required as a result of the event.There was no blood loss, and blood transfusion was not required due to the event.The catheter has been in place for eight months.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted one catheter, with a crack on the threads of its venous luer adapter.It was reported that the luer adapter was leaking.The reported issue was confirmed.The most likely cause could not be established from the information available.Internal process impro vements have been initiated to mitigate this issue.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.

• 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: 22096495
• Report Number: 1282497-2025-00357
• Device Sequence Number: 20800042
• Product Code: MSD
• UDI-Device Identifier: 10884521157989
• UDI-Public: 10884521157989
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123196
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: 8888145015P
• Device Catalogue Number: 8888145015P
• Device Lot Number: 2405800237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2024
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 64 KG