MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM; VASCULAR POLYESTER GRAFT

Model Number	M00202175132P0
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
((b)(4)) a review of the complaint device history records indicated that the graft was processed and inspected according to established tests and procedures and no anomaly was found.((b)(4)) no conclusion can be drawn.The investigation performed would tend to indicate that the product was not defective at the time of manufacturing.However, a non conformance report has been initiated in order to further investigate the root cause of the event and take appropriate corrective action if necessary.
Event or Problem Description
It was reported by the hospital two cases were the devices were found with no label for documentation and no direction for use in the packaging.The devices were used without any consequence for patients.The second case is submitted under manufacturer report number 1640201-2018-00003.

• Brand Name: HEMASHIELD PLATINUM
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7243513
• Report Number: 1640201-2018-00004
• Device Sequence Number: 1486198
• Product Code: MAL
• UDI-Device Identifier: 00384401018094
• UDI-Public: 00384401018094
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2018

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: 02/28/2022
• Device Model Number: M00202175132P0
• Device Catalogue Number: M00202175132P0
• Device Lot Number: 17C29
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1