MAUDE Adverse Event Report: PERFUSION SYSTEMS CANNULA 77208 ART ONE PIECE 8FR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	77208
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual inspection of the unopened device shows the luer cap is loose.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
It was reported that prior to use of dlp pediatric one-piece arterial cannulae, the cannulae caps were separated upon arrival.It was queried whether it was safe to use it in this condition.The barcode of the newly arrived product also seemed to be four digits longer than the previous one.The products were determined to be unusable.There was no patient involved.Medtronic received additional information that the issue was observed, when the customer inspected the goods after receiving them.There was no damaged observed to the caps.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection of the unopened device showed the luer cap was loose.The barcode was only on the outer box and not on the device.There was no other barcode with 4 digits shorter for analysis.The reason for return was confirmed for a loose component.Correction b5: it was reported that foreign material (fm) was found in the packaging of the dlp pediatric one-piece arterial cannulae prior to use.The cannulae were inspected by a government entity.The devices were not used or replaced.There was no patient involved.Additional information b5: medtronic received additional information that the sterile barriers were still sealed when fm was identified.Correction h6.3 (eval code result (fdr/annex c)): this code has been updated.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
Correction d4: unique identifier (udi) # updated.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: CANNULA 77208 ART ONE PIECE 8FR
• 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: 21470719
• Report Number: 2184009-2025-00345
• Device Sequence Number: 11675610
• Product Code: DWF
• UDI-Device Identifier: 00763000946739
• UDI-Public: (01)00763000946739(17)270814(10)2024080470(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K024069
• 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,Followup,Followup
• Report Date (Section B): 07/22/2025

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 Model Number: 77208
• Device Catalogue Number: 77208
• Device Lot Number: 2024080470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 03/10/2025; 07/21/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 04/03/2025; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• 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