MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC; GRAFT, VASCULAR

Model Number 175428P

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/17/2015

Event Type  malfunction  

Event Description

The graft was opened on the field at doctor's request.When he visualized the graft, he felt there was some adhesive visible on one end of the graft that should not be there.The graft was not used for this reason.The graft was removed from the field.A new graft, same size, was opened.

• Type of Device: GRAFT, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 5123702
• MDR Text Key: 27372810
• Report Number: 5123702
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/03/2015,09/11/2015

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
• Device Operator: No Information
• Device Model Number: 175428P
• Device Lot Number: 25095359
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 61