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

Model Number	8888135241
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Pain (1994); Chills (2191)
Date of Event	10/21/2024
Type of Reportable Event	Serious 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.
Event or Problem Description
According to the reporter, the patient had chronic kidney disease stage 5.On (b)(6) 2024 the patient underwent right inguinal catheterization under local anesthesia, and the operation went smoothly.On (b)(6) 2024 hemodialysis was performed respectively, and the blood sugar process went smoothly.On october 21, the patient developed fever, with a body temperature of 38.8, accompanied by chills, pain at the right inguinal catheterization site, no cough, sputum, frequent urination, urgency, or pain.Pe (physical examination) observations, a small amount of purulent secretions were seen at the right inguinal catheterization site, and the rest of the physical examination had nothing special.Considering catheter infection, ampicillin sodium and sulbactam sodium was added for anti-infection.
Additional Manufacturer Narrative
Additional information: b5, d6a, g3, h6 (fdm) 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, the patient had chronic kidney disease stage 5.On october 16, the patient underwent right inguinal catheterization under local anesthesia, and the operation went smoothly.On october 17, october 18, and october 19, hemodialysis was performed respectively, and the blood sugar process went smoothly.On october 21, the patient developed fever, with a body temperature of 38.8, accompanied by chills, pain at the right inguinal catheterization site, no cough, sputum, frequent urination, urgency, or pain.Pe (physical examination) observations, a small amount of purulent secretions were seen at the right inguinal catheterization site, and the rest of the physical examination had nothing special.Considering catheter infection, an oral medication ampicillin sodium and sulbactam sodium was added for anti-infection.There was nothing unusual observed on the device prior to use.Flushing was done prior to use.There was no leak and tego was not utilized.There were no luer adapter issue.There was no cleaning agent used on the device.The insertion site was treated with iodine wiped prior to product placement.There were no other defects/damages found on the product aside from the reported issue.There were no other products being utilized with the device.No excessive force was used on the device.As a remedial action, the catheter was replaced and the procedure was completed after resolving the issue.There was 2-3ml of blood loss and blood transfusion was not required due to the event.
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, the patient had chronic kidney disease stage 5.On (b)(6) the patient underwent right inguinal catheterization under local anesthesia, and the operation went smoothly.On october 17, october 18, and october 19, hemodialysis was performed respectively, and the blood sugar process went smoothly.On (b)(6), the patient developed fever, with a body temperature of 38.8, accompanied by chills, pain at the right inguinal catheterization site, no cough, sputum, frequent urination, urgency, or pain.Pe (physical examination) observations, a small amount of purulent secretions were seen at the right inguinal catheterization site, and the rest of the physical examination had nothing special.Considering catheter infection, an oral medication ampicillin sodium and sulbactam sodium was added for anti-infection.There was nothing unusual observe on the device prior to use.Flushing was done prior to use with no abnormality.There was no leak and tego was not utilized.There were no luer adapter issue.There was no cleaning agent used on the device.The insertion site was treated with iodine wiped prior to product placement.There were no other def ects/damages found on the product aside from the reported issue.There were no other products being utilized with the device.No excessive force was used on the device.As a remedial action, the catheter was replaced and the procedure was completed after resolving the issue.There was 2-3ml of blood loss and blood transfusion was not required due to the event.

• Brand Name: MAHURKAR
• Common Device Name: 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: 20786486
• Report Number: 1282497-2024-20029
• Device Sequence Number: 15186750
• Product Code: MPB
• UDI-Device Identifier: 10884521006539
• UDI-Public: 10884521006539
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 8888135241
• Device Catalogue Number: 8888135241
• Device Lot Number: 2327000134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 12/14/2024; 02/12/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/19/2024; 02/14/2025
• Date Device Manufactured: 11/17/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Male