MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC 12 MM 15CM HEMASHIELD MDV; VASCULAR GRAFT

Model Number M002020951120

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2015

Event Type  malfunction  

Event Description

The hosp reported that when the 12 mm 15cm hemashield mdv graft was delivered to the operating room, the outside shipping package was damaged.When the package was opened, the packaging with the graft was also damaged.It was uncertain whether the integrity of the sterile package was compromised.

Manufacturer Narrative

The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the eval is completed.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.There are no other similar complaints reported against this batch.(b)(4).

• Brand Name: 12 MM 15CM HEMASHIELD MDV
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): MAQUET CARDIOVASCULAR, LLC; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4502722
• MDR Text Key: 5533088
• Report Number: 2242352-2015-00024
• Device Sequence Number: 1
• Product Code: MAL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: M002020951120
• Device Lot Number: 25068569
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1