MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC 28MM 30CM HEMASHIELD PLAT WDV; VASCULAR GRAFT

Model Number M00202175428P0

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The hospital reported that they received the 28mm 30cm hemashield plat wdv with no outer packaging.This was noticed when the graft was received in the operating room prosthesis room.The hospital did not report any patient effects.

Manufacturer Narrative

The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.A lot history record review was completed for the reported product lot number.There was no non-conformance recorded in the lot history.(b)(4).

• Brand Name: 28MM 30CM HEMASHIELD PLAT WDV
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): MAQUET CARDIOVASCULAR, LLC; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097690
• MDR Report Key: 4073519
• MDR Text Key: 17690640
• Report Number: 2242352-2014-00703
• Device Sequence Number: 1
• Product Code: MAL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: M00202175428P0
• Device Lot Number: 25082005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1