MAUDE Adverse Event Report: SURGE CARDIOVASCULAR ANTEGRADE CARDIOPLEGIA CANNULA

Model Number ANT-1014S

Device Problem Device Packaging Compromised (2916)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint was confirmed by the returned part.The failure was a sterile barrier breach.

Event Description

The needle does not have the protective cover attached and it has perforated the packaging.

• Brand Name: ANTEGRADE CARDIOPLEGIA CANNULA
• Type of Device: ANTEGRADE CARDIOPLEGIA CANNULA
• Manufacturer (Section D): SURGE CARDIOVASCULAR; 2680 walker ave nw, suite c; walker MI 49544
• Manufacturer (Section G): SURGE CARDIOVASCULAR; 2680 walker ave nw, suite c; walker MI 49544
• Manufacturer Contact: kelli jonas ; 2680 walker ave nw, suite c; walker, MI 49544 ; 6162026120
• MDR Report Key: 7517939
• MDR Text Key: 108807229
• Report Number: 3004986960-2018-00002
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00817278010231
• UDI-Public: 00817278010231
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1