MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 8888135131

Device Problems Product Quality Problem (1506); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient had an internal jugular vein catheterization for hemodialysis due to uremia.The patient's internal jugular vein catheter and fixed suture device moved out/migrated from its position.It was said that the stitches held.Nothing unusual was observed on the device prior to use.There was no leak.Tego was not utilized.There was no luer adapter issue.Iodophor was the cleaning agent used on the device.Artificial liver link circuit was being utilized with the device.No part of the wing had failed and the ring of the suture wing was not broken.There was no blood loss and no blood transfusion was required.The patient had no medical intervention/treatment due to the event.The internal jugular vein fixation suture device as well as the catheter was removed and the patient had a reinsertion of internal jugular vein catheter as preliminary action.Treatment was completed.There was no reported patient injury.

• Brand Name: MAHURKAR
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15936939
• MDR Text Key: 307926068
• Report Number: 3009211636-2022-00428
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 20884521006208
• UDI-Public: 10884521006201
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2022

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
• Device Operator: Health Professional
• Device Model Number: 8888135131
• Device Catalogue Number: 8888135131
• Device Lot Number: 2011300093
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/07/2022
• Date Device Manufactured: 05/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1