MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	8888135163
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the catheter was installed on (b)(6) 2023 for hemodialysis, and after 5 hemodialysis sessions of 6 hours each, it presented a fissure and fluid leakage on the extension tube near the venous luer adapter when it was handled on the day of the event.Flushing (disinfection) was done before use, and when the catheter was tested with the syringe before starting the procedure, blood leakage was observed.The issue was only observed during the last hemodialysis session.There was nothing unusual observed on the device prior to use.Besides the reported issue, there were no other defects or damages found on the product where the leak was observed.The catheter was not repaired and was not possible to use.Tego was utilized, and there were no other products utilized with the device.Chlorhexidine was typically used to clean the adapters and the entire catheter.After cleaning, it was covered with sterile gauze, and there was no ointment applied.There was no excessive force used on the device.The insertion site was not treated prior to product placement.The catheter had been in place for six days.When the problem was identified, it was necessary to remove and change the device at the time of the event by the intensive care (which was meant by the personnel who worked in the intensive care unit (icu), which was the intensive care physician) to resolve the issue and to proceed with the other hemodialysis sessions.The treatment was completed after resolving the issue.The product was discarded as the client argued that it had already been in contact with blood for several days.There was a blood loss of less than 1 ml (milliliter), and blood transfusion was not required.There was no medical or surgical intervention needed to prevent a permanent impairment of a function.The event did not lead to or extend the patient's hospitalization.There was no reported patient injury.
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 one mahurkar catheter with a pinhole leak in the venous extension tube.Functional testing found that there was a cut, hole or disconnection in the extension tube which led to a leak.It was reported that there is a leak on the extension tube.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17695018
• Report Number: 3009211636-2023-00248
• Device Sequence Number: 2647525
• Product Code: MPB
• UDI-Device Identifier: 10884521006386
• UDI-Public: 10884521006386
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K030209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2024

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: 8888135163
• Device Catalogue Number: 8888135163
• Device Lot Number: 2226500175
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• 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: 80 YR
• Patient Sex: Male