MAUDE Adverse Event Report: PERFUSION SYSTEMS CANNULA 80222 ART MET TIP 22FR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	80222
Medical Device Problem Code	Decoupling (1145)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at medtronic's quality laboratory, visual inspection confirmed the metal tip was separated from the device.Medtronic's investigation is in progress.
Event or Problem Description
Medtronic received information that during de-cannulation, the metal tip separated from the body of this cannula.There were no adverse patient effects as a result of this product issue.
Additional Manufacturer Narrative
Conclusion: after investigation at medtronic and its supplier, the complaint of the metal tip being separated from the cannula body was confirmed.Additional evaluation did not note the appearance of any type of ultra-violet (uv) solvent residue on the metal tip or the inside of the adapter.Medtronic will continue to monitor for future occurrences and trends.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CANNULA 80222 ART MET TIP 22FR
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 6917629
• Report Number: 2184009-2017-00037
• Device Sequence Number: 483493
• Product Code: DWF
• UDI-Device Identifier: 20643169485741
• UDI-Public: 20643169485741
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K840002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2017

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: 07/31/2018
• Device Model Number: 80222
• Device Catalogue Number: 80222
• Device Lot Number: 201704C064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1