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

Model Number HGK0006-20

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Patient Involvement (2645)

Event Date 12/17/2018

Event Type  malfunction  

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 Description

The package was delivered completely soaked and damaged to the customer.The customer refused to accept it.

• Brand Name: HEMAGARD KNITTED
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• Manufacturer Contact: laure fraysse ; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8253375
• MDR Text Key: 134581654
• Report Number: 1640201-2019-00004
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401014041
• UDI-Public: 00384401014041
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2018
• 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