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

Model Number	8888233216
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
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, in order to preparation prior to insertion, saline was injected into each lumen, but it could not be injected into the center lumen (white) at all.It was mentioned that they could not pressed the plunger with a syringe for both negative and positive pressure.The catheter was not repaired and there was no leak.There was no cleaning agent used on the device.Tego was not utilized and there was no connector issue.They were not able to perform flushing.There were no other damages found on the product.The product was replaced with a new device of the same product id and out of the same box as the same date of the event to resolve the issue.There was no patient involvement.
Additional Manufacturer Narrative
Additional information: b5, d3 (mfr name, street 1, mfr city, mfr region, country code, postal code), 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.
Event or Problem Description
According to the reporter, in order to preparation prior to insertion, saline was injected into each lumen but it could not be injected into the center lumen (white) at all.It was mentioned that they could not press the plunger with a syringe for both negative and positive pressure.There was no problem with the syringe itself, and it was clearly stuck (blocked up) with lumens.The catheter was not repaired and there was no leak.There was no cleaning agent used on the device.Tego was not utilized and there was no connector issue.They were not able to perform flushing.There were no other damages found on the product.The product was replaced with a new device of the same product id and out of the same box as the same date of the event to resolve the issue.There was no patient involvement.
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 preparation for insertion, saline was injected into each lumen but it could not be injected into the center lumen (white) at all.It was mentioned that they could not press the plunger with a syringe for both negative and positive pressure.There was no problem with the syringe itself, and it was clearly stuck (blocked up) with lumens.The catheter was not repaired and there was no leak.There was no cleaning agent used on the device.Tego was not utilized and there was no connector issue.Flushing was performed but it could not be flushed.There were no other damages found on the product.The product was replaced with a new device of the same product id and out of the same box as the same date of the event to resolve the issue.There was no patient involvement.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the cannula tip was damaged, bent, or disconnected from the cannula as a result of a manufacturing issue.It was reported that the device was occluded.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.Internal process improvements have been initiated to mitigate this issue.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: 19006524
• Report Number: 3009211636-2024-00090
• Device Sequence Number: 9438671
• Product Code: NIE
• UDI-Device Identifier: 10884521127661
• UDI-Public: 10884521127661
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/21/2024

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: 8888233216
• Device Catalogue Number: 8888233216
• Device Lot Number: 2301000120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 03/26/2024; 07/16/2024; 08/05/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/22/2024; 08/05/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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: Unknown