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

Model Number	77014
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
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 at an unspecified time, this dlp pediatric one-piece arterial cannula was found to be marked as a 14fr and was indeed in a box labelled 14fr, however the actual size of the device was 12fr.The mandrel was indeed 14fr.Use of device was unspecified.There was no adverse patient effect reported with this event.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection of the opened device shows the cannula is labeled as a 14 fr.The obturator will not fit inside the cannula.The obturator od, and cannula od were measured using a keyence scope, the cannula id was measured using pin gage.The cannula id was measured using the keyence but with the id being out of round the pin gage was used.Cannula od was measured to be 0.169 inches, the 14 fr specification has the od to be 0.191 to 0.205 inches.Cannula id was measured to be 0.132 inches, the 14 fr specification has the id to be 0.154 to 0.160 inches.Obturator od was measured to be 0.148 inches, the 14 fr specification has the od to be 0.146 to 0.152 inches.The cannula 12 fr specification has the od to be 0.163 to 0.177 inches.The cannula 12 fr specification has the id to be 0.129 to 0.136 inches.Reason for return was confirmed for being labeled wrong.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
Additional information b5.The device was replaced.There was no patient involvement, so no adverse effect occurred.Correction e.Initial reporter street 1 postal code.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
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: ONE PIECE ARTERIAL CANNULAE
• 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: 20299651
• Report Number: 2184009-2024-00563
• Device Sequence Number: 12978510
• Product Code: DWF
• UDI-Device Identifier: 00763000091132
• UDI-Public: 00763000091132
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 12/18/2024

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: 77014
• Device Catalogue Number: 77014
• Device Lot Number: 2023121097
• 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: 10/21/2024; 12/06/2024; 12/18/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 11/14/2024; 12/17/2024; 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown