MAUDE Adverse Event Report: SURGE CARDIOVASCULAR ANTEGRADE CARDIOPLEGIA CANNULA

Model Number	ANT-1014S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was confirmed by the returned part.The failure was a sterile barrier breach.
Event or Problem Description
The needle does not have the protective cover attached and it has perforated the packaging.

• Brand Name: ANTEGRADE CARDIOPLEGIA CANNULA
• Common Device Name: ANTEGRADE CARDIOPLEGIA CANNULA
• Manufacturer (Section D): SURGE CARDIOVASCULAR; 2680 walker ave nw, suite c; walker MI 49544
• MDR Report Key: 7517939
• Report Number: 3004986960-2018-00002
• Device Sequence Number: 1607302
• Product Code: DWF
• UDI-Device Identifier: 00817278010231
• UDI-Public: 00817278010231
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K964198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 01/01/2018
• Device Model Number: ANT-1014S
• Device Catalogue Number: ANT-1014S
• Device Lot Number: 00712-012918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1