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

Model Number	HGK0006-20
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the involved product was returned to intervascular and was inspected by our quality assurance (qa) manager for an evaluation of the damage extent.His observations are as follows: the external packaging and the product box have arrived open and damaged.A tamper-evident label is torn off.There is a match between the labelling of the box and the external tyvek.The seals seem to have integrity.The product contained in the shell corresponds to the labelling.In conclusion, the product does not comply with the specifications due to a damaged outer packaging and a potential risk of degradation of the sterile barrier.Based on the light packaging in which the product was sent to the customer and the damage extent of both the external packaging and product box, it is assumed that the event occurred during transportation.(b)(4) the most likely cause of this event is an inappropriate transport of the device by our logistic subcontractor.
Event or Problem Description
The package was delivered completely soaked and damaged to the customer.The customer refused to accept it.

• Brand Name: HEMAGARD KNITTED
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8253375
• Report Number: 1640201-2019-00004
• Device Sequence Number: 14062035
• Product Code: DSY
• UDI-Device Identifier: 00384401014041
• UDI-Public: 00384401014041
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2018

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: 09/30/2023
• Device Model Number: HGK0006-20
• Device Catalogue Number: HGK0006-20
• Device Lot Number: 18K18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1