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

Model Number	8888145045
Medical Device Problem Code	Material Puncture/Hole (1504)
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, the product was rinsed before use, and the catheter extension tube was found to have trachoma and liquid leakage at the venous end near bifurcate.There was an unusual observation on the device prior to use.Flushing was done, and there was a leaking liquid.There was no excessive force used on the device.There was no cleaning agent used on the device.The tego was not utilized.There was no luer adapter issue.The insertion site was not treated prior to product placement.The catheter was not repaired.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.The reported product was replaced.There was no remedial action performed.There was no reported patient injury.
Event or Problem Description
According to the reporter, the product was rinsed before use, and the catheter extension tube was found to have trachoma and liquid leakage at the venous end near bifurcate.There was an unusual observation on the device prior to use.Flushing was done, and there was a leaking liquid.There was no excessive force used on the device.  there was no cleaning agent used on the device.The tego was not utilized.There was no luer adapter issue.The insertion site was not treated prior to product placement.The catheter was not repaired.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.The reported product was replaced.There was no remedial action performed.There was no reported patient injury.
Additional Manufacturer Narrative
G3 correction: e1 (phone number).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
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 that noted one catheter kit, with a red circle marked on its venous extension line.There appeared to be no abnormalities with the device.Functional testing found that the returned device was flushed and a pin-hole leak was spotted.It was reported that there was a leak on the extension tube at or near the bifurcate/hub.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur if the catheter came into contact with a sharp instrument during use.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: 21252012
• Report Number: 1282497-2025-00050
• Device Sequence Number: 9117423
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2025
• Supplement Date Received by Manufacturer: 02/07/2025; 06/19/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 02/12/2025; 06/20/2025
• 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