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

Model Number	M00202175410P0
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event date was set on (b)(6) 2021, as it was the day the product damage was detected by the customer during goods inspection.However, because the shipping container was intact, it is assumed that the event has occurred before this date.((b)(4)) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 21a27, the complaint #: (b)(4) excluded.((b)(4)) based on the pictures provided by the customer, the product damage was confirmed.It appears to be caused by a bad handling of the product box before shipping.((b)(4)) the conducted investigation confirmed that the product was defective when received by the customer, due to an handling issue of the product box, which may have occurred before shipping.Therefore, an internal non-conformity report has been initiated in order to investigate the root cause and to take appropriate corrective actions if necessary.
Event or Problem Description
At goods receipt, during incoming inspection performed by the customer (distributor), three products (b)(4) were refused due to a damage on the product box.However, the shipping carton was intact.Complaint # (b)(4).This mdr is part of a series of three mdrs involving the three nonconforming products.(serial numbers (b)(4)).

• Brand Name: HEMASHIELD PLATINUM WOVEN
• 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: 11788876
• Report Number: 1640201-2021-00013
• Device Sequence Number: 13708249
• Product Code: MAL
• UDI-Device Identifier: 00384401018322
• UDI-Public: (01)00384401018322
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2021

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: 12/31/2025
• Device Model Number: M00202175410P0
• Device Catalogue Number: M00202175410P0
• Device Lot Number: 21A27
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/07/2021
• Patient Sequence Number: 1