MAUDE Adverse Event Report: PERFUSION SYSTEMS EOPA ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	77418
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted as part of remediation activities associated with capa#: 643143, which is addressing mdr reporting guidance from fdas 1995 preamble, which ensures complaints related to corrections and recalls which were previously reported to fda under 21 cfr 806 are now reported as mdrs; this is not a new malfunction/event.Device evaluation summary: visual inspection shows the peel pouch of 3 unopened devices are labeled as 77418, 18 fr cannula.The devices inside the peel pouch are labeled as 77422, 22 fr.Reason for return was confirmed.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
Medtronic received information that prior to use of a eopa arterial cannulae, it was reported that the customer opened a new box of 77422 cannula (lot number: 2023020934) and it contained 17 packets labelled 77422 cannula and 3 packets labelled 77418 cannula.However, the 3 packets labelled as 18fr actually contained 22fr cannulae.The device was replaced.There was no patient involvement, so no adverse effect occurred.Additionally, there were no damage to the internal or external boxes.All cannulae packets were sealed inside.

• Brand Name: EOPA ARTERIAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22289499
• Report Number: 2184009-2025-00790
• Device Sequence Number: 8876277
• Product Code: DWF
• UDI-Device Identifier: 00763000135614
• UDI-Public: 00763000135614
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K031037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/19/2025

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: 02/08/2026
• Device Model Number: 77418
• Device Catalogue Number: 77418
• Device Lot Number: 2023020612
• 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: 11/22/2024
• Initial Report FDA Received Date: 06/19/2025
• Date Device Manufactured: 02/08/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0985-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown