MAUDE Adverse Event Report: MAQUET CV 16X8MM 40CM HEMA MDV BIF; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Catalog Number VS020851680

Device Problems Incomplete or Missing Packaging (2312); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2015 01:22 pm (gmt-4:00) added by (b)(6) ((b)(4)): 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 nonconformance recorded in the lot history.

Event Description

The hospital reported that they received the package damaged and no product was inside.

• Brand Name: 16X8MM 40CM HEMA MDV BIF
• Type of Device: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 5150323
• MDR Text Key: 28608534
• Report Number: 2242352-2015-01173
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: VS020851680
• Device Lot Number: 25100592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2015
• Date Device Manufactured: 07/11/2014
• 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