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

Model Number	77008
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	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 dlp pediatric one-piece arterial cannula, it was reported that the device had a 16fr cannula inside the pack instead of a 8fr.See attached photos.The device was used.There was no patient involvement, so no adverse effect occurred.
Additional Manufacturer Narrative
Correction device evaluation summary: the cannula od was measured, and it was not within the specification for the 8 fr cannula.The cannula id was measured, and it was not within the specification for the 8 fr cannula.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
Device evaluation summary: visual inspection of the opened device showed the peel pouch was for an 8 fr device and the cannula was labelled as a 16 fr.The obturator was very loose inside the cannula.The obturator outer diameter (od), cannula od and inner diameter (id) were measured.The cannula od was measured, and it was within the specification for the 16 fr cannula.The cannula id was measured, and it was within the specification for the 16 fr cannula.The obturator od was measured, and it was within specification for an 8 fr cannula.The reason for return was confirmed for having the wrong cannula.Correction b5: the device was not used.Correction h6.1 (device codes (fdd/annex a)): 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.

• Brand Name: PED. 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: 20299896
• Report Number: 2184009-2024-00565
• Device Sequence Number: 8883456
• Product Code: DWF
• UDI-Device Identifier: 00763000091101
• UDI-Public: 00763000091101
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/09/2024

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: 77008
• Device Catalogue Number: 77008
• Device Lot Number: 2024010723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 10/28/2024; 12/09/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 11/20/2024; 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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