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

Model Number	8888145041P
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, upon disconnection, a blood stain was observed on the sterile drape, and blood was noted around the venous clamp of the dialysis catheter.After cleaning the clamp, nothing abnormal was visible.Flushing of the venous branch showed no issues either.However, during a pressurized flush of the venous branch with the clamp closed and saline syringe injected under pressure, a leak was immediately observed at the branch level.The catheter was not repaired.There was a leak at the catheter shaft.There was no leaking at the junction of the bifurcate and catheter.Only sterile saline (physiological serum) was used.No chemical cleaning agents were applied on the device.Tego was not utilized.There was no luer adapter issue.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
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, upon disconnection, a blood stain was observed on the sterile drape, and blood was noted around the venous clamp of the dialysis catheter.After cleaning the clamp, nothing abnormal was visible.Flushing of the venous branch showed no issues either.However, during a pressurized flush of the venous branch with the clamp closed and saline syringe injected under pressure, a leak was immediately observed at the branch level.The catheter was not repaired.There was no leaking at the junction of the bifurcate and catheter.Only sterile saline (physiological serum) was used.No chemical cleaning agents were applied on the device.Tego was not utilized.There was no luer adapter issue.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 ; 8006464633
• MDR Report Key: 23653708
• Report Number: 1282497-2025-00652
• Device Sequence Number: 18655640
• Product Code: MSD
• UDI-Device Identifier: 10884521158047
• UDI-Public: (01)10884521158047(17)280813(10)2324100193
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 8888145041P
• Device Catalogue Number: 8888145041P
• Device Lot Number: 2324100193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/04/2025
• Date Device Manufactured: 09/14/2023
• 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