MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC 8 MM 15CM HEMASHIELD MDV; VASCULAR GRAFT

Model Number M002020951080

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 06/02/2014

Event Type  malfunction  

Event Description

The hosp reported that the 8 mm 15cm hemashield mdv graft arrived and the outer shipping container was in good condition.When it was opened the packaging as crushed and there was a question of the sterility of the graft.

Manufacturer Narrative

Since the device is not available to be returned to us, a technical eval cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.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: 8 MM 15CM HEMASHIELD MDV
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097690
• MDR Report Key: 4092547
• MDR Text Key: 4762249
• Report Number: 2242352-2014-00736
• Device Sequence Number: 1
• Product Code: MAL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954848
• 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: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: M002020951080
• Device Lot Number: 25086616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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