MAUDE Adverse Event Report: COVIDIEN LLC MAHURKAR ELITE; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 8888211224

Device Problems Break (1069); Defective Component (2292)

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

Event Date 10/27/2023

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, when sealing the tube right after the implantation, it was found that the inner diameter of the external arterial (red) connector and venous (blue) connector was larger than that of the catheter used in the past, which caused the syringe and the external connector to not be tightly connected, and resulted in the risk of blood, fluid and air leakage.It was also stated that there was a leak located at the venous (blue) luer adapter, and no crack was observed with the luer adapter.There was nothing unusual observed on the device prior to use.Besides the reported issue, there were no other visible defects/damages found on the product where the leak was observed.Flushing was done prior to use with no problem with the result.Tego was not utilized, and there were no other products utilized with the device.The adapters were tightened by hand.There was no excessive force used on the device.There was no cleaning agent used on the device, and there was no cleaning agent utilized to clean the adapters.The insertion site was not handled prior to product placement.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.The catheter was not repaired.There was no remedial action done to resolve the issue.The reported catheter was not replaced, had not been not removed, and currently under close observation.The procedure was completed.There was a blood loss of 3 milliliters (ml), and a blood transfusion was not required due to the event.There was no reported patient injury.

Manufacturer Narrative

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.However, a video was provided.The evaluation found no potentially contributing factors.It was reported that the luer adapter was leaking, cracked or broken and there was a dimension/connection issue with the luer adapter.The reported issues could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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: MAHURKAR ELITE
• Type of Device: CATHETER, HEMODIALYSIS, NON-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: 18176743
• MDR Text Key: 328639167
• Report Number: 3009211636-2023-00313
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521125391
• UDI-Public: 10884521125391
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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
• Device Operator: Health Professional
• Device Model Number: 8888211224
• Device Catalogue Number: 8888211224
• Device Lot Number: 2234600069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2022
• 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