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

Model Number	8888135131
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the patient with chronic kidney disease (stage 5) went to the catheterization room for right internal jugular vein catheterization at 13:30.The surgery went smoothly, the depth of vein insertion was 13.5 cm (centimeter), and the exposed length of the catheter was 0 cm.There was no bleeding or exudation at the puncture site, and there was no hematoma on the surrounding skin.The dressing was dry and clean, and ice was applied to the place where the catheter was inserted.The patient was escorted to the radiology department for a chest x-ray examination and then returned to the ward.Hemodialysis treatment was performed at 15:00.1 day after the catheter had been in place, during the evaluation before getting on the hemodialysis machine, it was found that there was a little blood stain on the pipeline which meant extension tube.The exact location of the leak on the catheter was the blue extension tube near the adapter.No new blood stain was found after disinfection.After the hemodialysis machine was put on, the pipeline was wrapped with 75% alcohol gauze.When the hemodialysis machine was put off at 17:38, a small amount of blood was found on the dressing.The inspection revealed that there was a small hole in the pipeline and leaking blood.The patient was undergoing hemodialysis, and the risk of blood infection would increase if there was a small hole of blood leakage in the dialysis pipeline.Nothing unusual observed on the device prior to use.No cleaning agent used on the device.The clamp was not moved periodically.Flushing was done prior to use and no exception found.The product/tube was replaced with the same product id (identifier) on the same day as remedial action performed and the treatment was completed.A few milliliters the amount of blood lost.Blood transfusion was not required.There was no reported patient outcome.
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 with chronic kidney disease (stage 5) went to the catheterization room for right internal jugular vein catheterization at 13:30.The surgery went smoothly, the depth of vein insertion was 13.5 cm (centimeter), and the exposed length of the catheter was 0 cm.There was no bleeding or exudation at the puncture site, and there was no hematoma on the surrounding skin.The dressing was dry and clean, and ice was applied to the place where the catheter was inserted.The patient was escorted to the radiology department for a chest x-ray examination and then returned to the ward.Hemodialysis treatment was performed at 15:00.1 day after the catheter had been in place, during the evaluation before getting on the hemodialysis machine, it was found that there was a little blood stain on the pipeline which meant extension tube.The exact location of the leak on the catheter was the blue extension tube near the adapter.No new blood stain was found after disinfection.After the hemodialysis machine was put on, the pipeline was wrapped with 75% alcohol gauze.When the hemodialysis machine was put off at 17:38, a small amount of blood was found on the dressing.The inspection revealed that there was a small hole in the pipeline and leaking blood.The patient was undergoing hemodialysis, and the risk of blood infection would increase if there was a small hole of blood leakage in the dialysis pipeline.Nothing unusual observed on the device prior to use.No cleaning agent used on the device.The clamp was not moved periodically.Flushing was done prior to use and no exception found.The product/tube was replaced with the same product id (identifier) on the same day as remedial action performed and the treatment was completed.A few milliliters the amount of blood lost.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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that there was a cut in the extension tube which led to a leak.It was reported that there was a leak on the extension tube near the luer adapter.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur by clamping the tubing too close to the luer adapter.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: clamping repeatedly on the same spot could weaken the tubing and clamping near the adapter and hub should be avoided.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
• 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: 19144003
• Report Number: 1282497-2024-00055
• Device Sequence Number: 12728208
• Product Code: MPB
• UDI-Device Identifier: 10884521006201
• UDI-Public: 10884521006201
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2024

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: 8888135131
• Device Catalogue Number: 8888135131
• Device Lot Number: 2320000101
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/19/2024; 07/30/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/03/2024; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• 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 Age: 38 YR
• Patient Sex: Female