MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM WOVEN STRAIGHT; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Model Number	M00202175128P0
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event date was set on (b)(6) 2021, as is was the day the product damaged was detected by the customer.The damage to the products occurred between the day of shipment and the day of receipt, which is between (b)(6) 2021 and (b)(6) 2021.(4109/212) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 21g21.(4112/3236) as the defects appear obvious, a visual inspection based on pictures received was performed by our qa supervisor.Her conclusion are as follows: "i confirm that the two products in the state are not in conformity.A damage during transportation seems to be the most probable root cause." (4308) the most probable root cause of this event is an improper handling of the package during transport.An internal non-conformity report has been initiated in order to take appropriate action.
Event or Problem Description
This mdr is part of a series of 2 complaints involving 2 products delivered in same parcel and related to a single event.Both products were delivered damaged, as the inner packing was crushed.Complaint: #(b)(4).

• Brand Name: HEMASHIELD PLATINUM WOVEN STRAIGHT
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• MDR Report Key: 12631884
• Report Number: 1640201-2021-00032
• Device Sequence Number: 19906010
• Product Code: MAL
• UDI-Device Identifier: 00384401018070
• UDI-Public: (01)00384401018070
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

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: 06/30/2026
• Device Model Number: M00202175128P0
• Device Catalogue Number: M00202175128P0
• Device Lot Number: 21G21
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/14/2021
• Patient Sequence Number: 1