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

Model Number	8888145040P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during the dialysis treatment, the catheter had a broken venous adapter and hub.Besides the reported issue, a tear was found on the product at the time of the event.The catheter was not repaired.Tego was not utilized.The patient was not treated under general or local anesthesia.There was nothing unusual observed on the device prior to use.Flushing was done prior to use, and the result was unremarkable.Other products being utilized with the device included circuits and extensions.The customer was using a competitor's extension lines with the catheter and a competitor's caps.Excessive force was not used on the device.The cleaning agent used on the device was octenisept, which was also typically utilized to clean the catheter in its entirety.Lavanide was used on demand at the skin exit site.The wound dressing utilized was a leukomed patch, which did not include any cleaning agents or antimicrobial properties.The cleaning agents were allowed to dry thoroughly prior to applying ointment to the area and p rior to dressing the area.The patient was not responsible for any type of catheter maintenance, cleaning, or dressing changes.The cleaning agents were never switched over the life of the catheter and were never mixed.Sepsiderm was not used to clean catheters at the site.There was no protocol change for cleaning agents used recently.The patient themselves was not using any type of cleaning agent or antibiotic on the catheters.The insertion site was treated prior to product placement.There was no leak.The remedial action performed was the use of the arterial limb.No intervention or treatment was required as a result of the event.There was no blood loss, and no blood transfusion was required due to the event.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, during the dialysis treatment, the catheter had a broken and leaking venous adapter/connector/hub.There was no tear.The catheter was not repaired.Tego was not utilized.The patient was not treated under general or local anesthesia.There was nothing unusual observed on the device prior to use.Flushing was done prior to use, and the result was unremarkable.Other products being utilized with the device included circuits and extensions.The customer was using a competitor's extension lines with the catheter and a competitor's caps.Excessive force was not used on the device.The cleaning agent used on the device was octenisept, which was also typically utilized to clean the catheter in its entirety.Lavanide was used on demand at the skin exit site.The wound dressing utilized was a leukomed patch, which did not include any cleaning agents or antimicrobial properties.The cleaning agents were allowed to dry thoroughly prior to applying ointment to the area and prior to dressing the area.The patient was not responsible for any type of catheter maintenance, cleaning, or dressing changes.The cleaning agents were never switched over the life of the catheter and were never mixed.Sepsiderm was not used to clean catheters at the site.There was no protocol change for cleaning agents used recently.The patient themselves was not using any type of cleaning agent or antibiotic on the catheters.The insertion site was treated prior to product placement.The remedial action performed was the use of the arterial limb.No intervention or treatment was required as a result of the event.There was no blood loss, and no blood transfusion was required due to the event.There was no reported patient injury.
Additional Manufacturer Narrative
Correction: d4(unique identifier (udi) #).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, h3 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.A different image was submitted that did not show the reported condition.A comprehensive examination could not be performed, because the returned sample was not received in a state that allowed full functional or visual assessment.It was reported that luer adapter was leaking and broken.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.

• 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: 22111322
• Report Number: 1282497-2025-00370
• Device Sequence Number: 19876585
• Product Code: MSD
• UDI-Device Identifier: 10884521158030
• UDI-Public: (01)10884521158030(17)290325(10)2335200427
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 08/06/2025

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: 8888145040P
• Device Catalogue Number: 8888145040P
• Device Lot Number: 2335200427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 05/26/2025; 08/05/2025; 08/04/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/03/2025; 08/05/2025; 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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: 75 YR
• Patient Sex: Unknown
• Patient Weight: 91 KG