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, during dialysis treatment, after the catheter had been implanted, it was found to have a crack at the luer connector.The cleaning agent used on the device was iodophor.There was nothing unusual observed on the device prior to use.Flushing was done with normal result.There were other products being utilized with the device.There was no excessive force used on the device.As a remedial action and intervention/treatment, the catheter was replaced.The procedure was continued and completed.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.There was no blood loss, and a blood transfusion was not required due to the event.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: g3 correction: b5 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 the dialysis treatment, after the catheter was implanted, a crack was discovered at the luer connector.Prior to use, the device showed no unusual defects or damages, and flushing produced normal results.The cleaning agent used was iodophor.Other products were used with the device, and no excessive force was applied.Besides the reported crack, no other visible defects or damages were found on the product at the time of the event.As a remedial action, the catheter was replaced, and the procedure was continued and completed successfully.There was no blood loss and no blood transfusion was required.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: jon cornell ; 15 hampshire street; mansfield, MA 02048 ; 8772111850
• MDR Report Key: 23550414
• Report Number: 1282497-2025-00650
• Device Sequence Number: 13205315
• Product Code: MSD
• UDI-Device Identifier: 10884521157972
• UDI-Public: (01)10884521157972(17)290630(10)241970265(20)01
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: 241970265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 11/17/2025
• Date Device Manufactured: 07/15/2024
• 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