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

Model Number	8888145039P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, about half a year had passed since the patient¿s catheter was placed.Although no procedure (operation) was performed that applied non-human force (loads), such as the use of forceps, hub breakage (cracks can be visually confirmed) occurred during dialysis treatment.A crack was observed in the connector.There was no leak.Tego was not used.Closed plugs were used to loosen and tighten the connection.Nothing unusual was observed on the device prior to use.No other products are being utilized with the device.No other visible defects/damages were found on the product.Alcohol was the cleaning agent that was typically utilized to clean the catheter in its entirety.Sepsiderm was not used to clean the catheters.There was no protocol change for cleaning agents.The patient was not using any type of cleaning agents or antibiotics on the catheter.The intervention/treatment and remedial action required as a result of the event were catheter removal and insertion.There was no blood loss, and blood transfusion was not required.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: b5, 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 one catheter had visible signs of use.There were no cracks present on the bifurcate hub, however, cracks were spotted on both the arterial and the venous luer adapters.It was reported that the device was cracked, broken or leaking.The reported issue could not be confirmed.The most likely cause could not be established from the information available.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, about half a year had passed since the patient¿s catheter was placed.Although no procedure (operation) was performed that applied non-human force (loads), such as the use of forceps, hub breakage (cracks can be visually confirmed) occurred during dialysis treatment.There was no leak.Tego was not used.Closed plugs were used to loosen and tighten the connection.Nothing unusual was observed on the device prior to use.No other products are being utilized with the device.No other visible defects/damages were found on the product.Alcohol was the cleaning agent that was typically utilized to clean the catheter in its entirety.Sepsiderm was not used to clean the catheters.There was no protocol change for cleaning agents.The patient was not using any type of cleaning agents or antibiotics on the catheter.The intervention/treatment and remedial action required as a result of the event were catheter removal and insertion.There was no blood loss, and blood transfusion was not 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22096611
• Report Number: 1282497-2025-00351
• Device Sequence Number: 7866349
• Product Code: MSD
• UDI-Device Identifier: 10884521158023
• UDI-Public: 10884521158023
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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: 8888145039P
• Device Catalogue Number: 8888145039P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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