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)
Date of Event	12/26/2024
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 was admitted to the hospital on (b)(6) 2024, for a physical examination, and the temperature (t) was 36.4 degrees celsius, pulse (p) was 86 times per minute, respiratory rate (r) was 20 times per minute, and blood pressure (bp) was 148/64 millimeters of mercury.Under auxiliary examination, in the blood routine (blood test), white blood cell count was 6.71 × 10^9 per liter, and the neutrophil percentage was 65.5%.Due to uremia, hemodialysis was performed at 11:00 on (b)(6).The weight before dialysis was 44.3 kilograms.A blood access was established through the right inguinal vein catheterization; after hemodialysis treatment, the patient returned to the ward safely.The dressing at the right inguinal catheterization site was dry, there was no blood oozing, there were no complaints of discomfort, and the body temperature was 36.4 degrees celsius.Hemodialysis was performed regularly on the 25th and 26th.On (b)(6) 2024, at 21:05, the patient developed a high fever with a body temperature of 38.8 degrees celsius.The white blood cell count was 13.52*10^9 per liter elevated, the neutrophil percentage was 87.6% increased, the hemoglobin was 44 grams per liter decreased, the platelet count was 230*10^9 per liter, the c-reactive protein was 35.40 milligrams per liter elevated, and the procalcitonin was 0.671 nanograms per milliliter elevated.Considering that the right inguinal catheter had been placed for a long time and caused a catheter infection, the catheter was removed, the catheter was replaced, re -catheterization was done, and anti-infection treatment was given as preliminary actions.

• 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: 21567563
• Report Number: 1282497-2025-00129
• Device Sequence Number: 4430649
• 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 Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/10/2025
• 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: Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Unknown