MAUDE Adverse Event Report: COVIDIEN LLC MAHURKAR ELITE; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPL

Model Number	8888233220
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during the insertion procedure, the customer installed the catheter and noticed blood leakage in the extension proximally under the clamp.It happened at the anesthesiologist department.The catheter was not repaired.There was no luer adapter issue.Tego was not utilized.The insertion site was treated prior to product placement.Nothing unusual was observed on the device prior to use.There was an observation of fluid leakage from the cvk leg (triple lumen catheter and it¿s the middle leg for i.V fluids ) just inferior to the luer lock (luer adapter).The leak was located just proximal from the luer adapter.No report on the reason for the leakage.No other products were utilized with the device.The catheter was replaced with a catheter from the same supplier.There was no cleaning agent used on the device.The remedial action performed was the placement of a triple lumen dialysis catheter and the procedure was completed.There was no blood loss, and blood transfusion was not required.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.

• Brand Name: MAHURKAR ELITE
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPL
• 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: 20200945
• Report Number: 1282497-2024-00383
• Device Sequence Number: 12648904
• Product Code: NIE
• UDI-Device Identifier: 10884521127685
• UDI-Public: 10884521127685
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K120674
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8888233220
• Device Catalogue Number: 8888233220
• 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: 08/21/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 12/02/2024
• 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 Sex: Unknown