MAUDE Adverse Event Report: PERFUSION SYSTEMS MC2 TWO STAGE VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	91265
Medical Device Problem Codes	Contamination (1120); Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of a mc2 two stage venous cannula, it was reported the packaging was damaged.The device was replaced with 91265 cannula.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that there was a hole in the outer packaging of the cannula.There were no missing or wrong devices or components in the package.The product was not used.The sterile seal was intact.The device was sealed/located in the 'seal'.The package is unopened and cannot be confirmed if there was foreign material (fm) present.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows evidence of damage/hole in the tyvek portion of the peel pouch.Reason for return was confirmed.This regulatory report is being submitted as part of a retrospective review and remediation as part of a capa action.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: MC2 TWO STAGE VENOUS 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: 23841843
• Report Number: 2184009-2025-01648
• Device Sequence Number: 9958923
• Product Code: DWF
• UDI-Device Identifier: 00613994887412
• UDI-Public: (01)00613994887412(17)250707(10)2022070280
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K251258
• 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
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: 07/07/2025
• Device Model Number: 91265
• Device Catalogue Number: 91265
• Device Lot Number: 2022070280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• 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