MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD KNITTED; VASCULAR POLYESTER GRAFT

Model Number	HEMAGARD KNITTED GRAFT
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for evaluation.A mismatch between the graft (woven graft, length 30 cm, diameter 30mm) and its labeling (knitted graft, length 40 cm, diameter 16mm) was confirmed.It was noticed that both inner and outer blisters were open.Upon investigation and review of the complaint device history records, it appears that this discrepancy is related to an isolated human error which occured during a manufacturing step.As a correction, the corresponding mislabeled product was found in turkey as it was also returned to the sales and service unit as part of a complaint (see manufacturer report 1640201-2017-00013).As a corrective action, a working group is currently conducting an analysis of the issue to prevent such incident from reoccurring.
Event or Problem Description
When opening the blister in operating room, the customer noticed that the graft was of a different size than it was stated on the labeling (probably 30 mm in diameter instead of 16 mm as mentioned on the labeling).The device was not used and was returned for evaluation.

• Brand Name: HEMAGARD KNITTED
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6543324
• Report Number: 1640201-2017-00012
• Device Sequence Number: 16427680
• Product Code: DSY
• UDI-Device Identifier: 00384401014287
• UDI-Public: 00384401014287
• Combination Product (Y/N): N
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 07/31/2020
• Device Model Number: HEMAGARD KNITTED GRAFT
• Device Catalogue Number: HGK0016-40
• Device Lot Number: 15H06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 05/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1