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

Model Number	8888145017
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2024
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, after the patient had a catheter inserted on (b)(6) 2024, the patient underwent dialysis three times a week.After the catheter had been used for one month, when vigorously pumping and pushing the catheter (which meant by use a syringe to connect the catheter connector to aspirate and inject blood in order to check whether there was thrombus in the catheter and to test the patency of the catheter) before getting on the machine on (b)(6), found that there was spotty oozing blood at the red catheter port and there might be a sand-hole that was invisible to the naked eye, resulting to this oozing blood.No other products being utilized with the device.They immediately stopped using the catheter.Re-catheterization was performed, the product was replaced with the same id (identifier) and continued the treatment.There was no reported patient outcome.
Event or Problem Description
According to the reporter, after the patient had a catheter inserted on (b)(6) 2024, the patient underwent dialysis three times a week.After the catheter had been used for one month, when vigorously pumping and pushing the catheter (which meant by use a syringe to connect the catheter connector to aspirate and inject blood in order to check whether there was thrombus in the catheter and to test the patency of the catheter) before getting on the machine on february 27, found that there was spotty oozing blood at the red catheter port and there might be a sand-hole that was invisible to the naked eye, resulting to this oozing blood.No other products being utilized with the device.They immediately stopped using the catheter.Re-catheterization was performed, the product was replaced with the same id (identifier) and continued the treatment.There was no reported patient outcome.
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.
Additional Manufacturer Narrative
Additional information: g3, h6 information received shows this event is a duplicate of another issue reported under 3009211636-2024-00081.This file will be closed and all further updates processed under the above-referenced report for this event.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: 19353939
• Report Number: 1282497-2024-00122
• Device Sequence Number: 7678017
• Product Code: MSD
• UDI-Device Identifier: 10884521013193
• UDI-Public: 10884521013193
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111372
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2024

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: 8888145017
• Device Catalogue Number: 8888145017
• Device Lot Number: 2302700101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 05/10/2024; 05/29/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/04/2024; 06/26/2024
• Date Device Manufactured: 01/28/2023
• 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: Female