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

Model Number	8888145041P
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
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 its first hemodialysis use of the right internal jugular vein (rij) catheter, there was a small amount of blood coming from the clear tubing below the hub.This blood was wiped away, and no fault was able to be seen; however, 2.5 hours into hemodialysis, there was about 20 milliliters of blood that had leaked onto the patient¿s shirt.The clamp had been placed between the hub and fault, and they were hopeful this would prevent any further bleeding at the moment.There was no reported patient outcome.
Event or Problem Description
According to the reporter, during its first hemodialysis use of the right internal jugular vein (rij) catheter, there was a small amount of blood coming from the venous clear tubing below the hub.This blood was wiped away, and no fault was able to be seen; however, 2.5 hours into hemodialysis, there was blood leak onto the patient¿s shirt.Chlorhexidine 70%, and 20% alcohol with red tint were the cleaning agents used on the device.The clamp had been placed between the hub and fault, and they were hopeful this would prevent any further bleeding at the moment and the treatment was completed.The product was removed to resolve the issue.The extension tube was not repaired.No exchange necessary as patient ceased dialysis.There were 20 milliliters of blood loss.Blood transfusion was not required.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: a5a, a5b, b5, 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
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during its first hemodialysis use of the right internal jugular vein (rij) catheter, there was a small amount of blood coming from the venous clear tubing below the hub.This blood was wiped away, and no fault was able to be seen; however, 2.5 hours into hemodialysis, there was blood leak onto the patient¿s shirt.Chlorhexidine 70%, and 20% alcohol with red tint were the cleaning agents used on the device.The clamp had been placed between the hub and fault, and they were hopeful this would prevent any further bleeding at the moment and the treatment was completed.The product was removed to resolve the issue.The extension tube was not repaired.No exchange necessary as patient ceased dialysis.There were 15 milliliters of blood loss.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: 19499460
• Report Number: 1282497-2024-00154
• Device Sequence Number: 6661208
• Product Code: MSD
• UDI-Device Identifier: 10884521158047
• UDI-Public: 10884521158047
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2024

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: 2228000088
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 06/25/2024; 07/09/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/10/2024; 07/26/2024
• Date Device Manufactured: 12/02/2022
• 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: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White