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

Model Number	8888145043
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
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, fluid leakage was found and cracks were observed on the blue (venous) adapter end.The catheter was repaired.Iodine was the cleaning agent used on the device.Tego was not utilized.An instrument was used on the adapter surface to loosen or tighten the device.There was no reported patient injury.
Event or Problem Description
According to the reporter, during dialysis, fluid leakage was found, and cracks were observed on the blue (venous) adapter end.The catheter was repaired by replacing the damaged adapter.Iodine was the cleaning agent used on the device.Tego was not utilized.The crack was visible to the naked eye, and no other instrument was used on the adapter surface to loosen or tighten the device.Tubing was used to connect the luer adapter.There was an unusual observation on the device's adapter, as it was broken after connecting the tubing prior to use.Flushing was done before use, and there was a little liquid leakage.Domestic tubing was another product being utilized with the device.Betadine was the cleaning agent typically used to clean the adapters.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.No excessive force was used on the device.As remedial actions, the broken adapter was replaced, and the reported catheter was replaced with the same lot and id.The catheter could be used normally, and subsequent dialysis treatment was continued and completed after the remedial actions were done.There was no blood loss, and no blood transfusions were required due to the event.There was no medical intervention/treatment required as a result of the event.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: b5, d6a, d6b, g3.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
Correction: b5 additional information: g3, h3, h6 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 the luer adapter was cracked.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 can occur from overtightening the luer 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 dialysis, fluid leakage was found, and cracks were observed on the surface of the blue (venous) adapter end.The catheter was repaired by replacing the damaged adapter.Iodine was the cleaning agent used on the device.Tego was not utilized.The crack was visible to the naked eye, and no other instrument was used on the adapter surface to loosen or tighten the device.Tubing was used to connect the luer adapter.There was an unusual observation on the device's adapter, as it was broken after connecting the tubing prior to use.Flushing was done before use, and there was a little liquid leakage.Domestic tubing was another product being utilized with the device.Betadine was the cleaning agent typically used to clean the adapters.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.No excessive force was used on the device.The catheter was in place for 3 months.As remedial actions, the broken adapter was replaced, and the reported catheter was replaced with the same lot and id (identifier) on the same day.The catheter could be used normally, and subsequent dialysis treatment was continued and completed after the remedial actions were done.There was no blood loss, and no blood transfusions were required due to the event.There was no medical intervention/treatment required as a result of the event.There was no reported patient injury.
Additional Manufacturer Narrative
Correction: d4(unique identifier (udi) #) additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted a crack on the threads of the venous luer adapter of the catheter.It was reported that the luer adapter was leaking, cracked, and broken.The reported issue was confirmed.The most likely cause could not be established from the information available.Internal process improvements 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: 21851681
• Report Number: 1282497-2025-00243
• Device Sequence Number: 7963022
• Product Code: MSD
• UDI-Device Identifier: 10884521013223
• UDI-Public: (01)10884521013223(17)261025(10)2326900118
• 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 Implanted Year: 2025
• Device Explanted Year: 2025
• 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,Followup,Followup,Followup
• Report Date (Section B): 09/16/2025

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: 8888145043
• Device Catalogue Number: 8888145043
• Device Lot Number: 2326900118
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 04/25/2025; 06/16/2025; 09/12/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 04/30/2025; 06/17/2025; 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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 Age: 34 YR
• Patient Sex: Male
• Patient Weight: 45 KG