MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINIUM WOVN DOUBLE VELOUR; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Model Number	M00202175208P0
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/07/2019
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) supervisor for an evaluation of the damage extent.His observations are as follows: "the outer packaging was not opened, the outer packaging is damaged but there is no visible moisture (the cardboard is not curled, no ink), the inner packaging is neither opened nor damaged." the investigation is ongoing.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
The customer has received the wet parcel and he can't accept it.
Additional Manufacturer Narrative
(10/4246) following the inspection of the quality assurance (qa) supervisor, a non-conformity report was opened.After investigation the conclusion is that the event is due to a logistic issue.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same lot number.(4308) the most likely cause of this event is an inappropriate handling of the product during transport by our logistic subcontractor.The root cause remains unknown.An information about this discrepancy had been sent to our logistic subcontractor.
Event or Problem Description
See initial report.

• Brand Name: HEMASHIELD PLATINIUM WOVN DOUBLE VELOUR
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9294936
• Report Number: 1640201-2019-00082
• Device Sequence Number: 11463474
• Product Code: MAL
• UDI-Device Identifier: 00384401018148
• UDI-Public: 00384401018148
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: M00202175208P0
• Device Catalogue Number: M00202175208P0
• Device Lot Number: 19H28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1