MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR ELITE; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPL

Model Number	8888233420
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, when the catheter was disconnected from the patient, the clip did not close completely on the red port.It was stated that the red port was clamped and when it was disconnected from the continuous renal replacement therapy (crrt) machine, an air was noticed in the red port, and hemostats was then quickly used on the red port and the air was withdrew with a syringe.It was stated that the clamp on the port was not functioning properly.There was no reported patient outcome.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional info: b5, d6a, e1 (facility name, street 1, city, region, country, postal code), g3, h6 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, when the catheter was disconnected from the patient, the white clip did not close completely on the access tubing/red line.It was stated that the access tube/red line was clamped and when it was disconnected from the continuous renal replacement therapy (crrt) machine the primary nurse noticed an air in the access tubing/red line, it was mentioned that the clamp on the port was not functioning properly, to resolve the issue hemostats was quickly used on the red port and the air was withdrew using a syringe.The catheter was not repaired.There was no leak and luer adapter issue.There was nothing unusual observed on the device prior to use, no other defects/damages were found on the product, excessive force was not used on the device, no intervention/treatment was required as a result of the event.There was no blood loss and blood transfusion was not required due to the event.The patient was stable after the issue was resolved.There was no reported patient injury.

• Brand Name: MAHURKAR ELITE
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPL
• 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: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 13928457
• Report Number: 3009211636-2022-00078
• Device Sequence Number: 1790231
• Product Code: NIE
• UDI-Device Identifier: 10884521788732
• UDI-Public: 10884521788732
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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 Expiration Date: 09/01/2022
• Device Model Number: 8888233420
• Device Catalogue Number: 8888233420
• Device Lot Number: 2123600083
• 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: 03/10/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 04/14/2022
• 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