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

Model Number	8888145044
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the catheter was used for more than one month and the luer adapter (arterial) ruptured.The catheter was repaired.There was a leak and crack observed in the red (arterial) luer adapter.There was no instrument used to loosen or tighten the product, and there was no cleaning agent(s) used on the product.Tego was not utilized.The catheter was replaced.There was no reported patient injury.
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.
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, the catheter was used for more than one month and the luer adapter (arterial) ruptured.Prior to use, there was a crack observed in the red (arterial) luer adapter.Aside from the crack, there were no other defects found where the leak was observed.There was no instrument used to loosen or tighten the product, and there was no cleaning agent(s) used on the product.Tego was not utilized.The catheter was explanted and was replaced with another one with a different product id on the same day of the event.The procedure was completed after the remedial action.There was no treatment required due to the event.There was no blood loss, and blood transfusion was not required.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the luer adapter was leaking, cracked or broken.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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: 20506965
• Report Number: 1282497-2024-00446
• Device Sequence Number: 18225335
• Product Code: MSD
• UDI-Device Identifier: 10884521013247
• UDI-Public: 10884521013247
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted 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,Followup
• Report Date (Section B): 01/07/2025

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: 8888145044
• Device Catalogue Number: 8888145044
• Device Lot Number: 2302600115
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 11/25/2024; 12/17/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/27/2024; 01/07/2025
• 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