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

Model Number	M00202175208P0
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the product is available for investigation, it should be returned to intervascular for examination.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 21f02.The investigation is still ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
This is a case of a product damaged during transportation.The product was damaged when it arrived at the end customer.Shipment was rejected by the customer because the shipment box was wet and damaged.
Additional Manufacturer Narrative
Corrected data: block d4: there was an error in the expiry date in the initial report, it is 31 may 2026.Block e2 and e3: there was an error in the initial report, the initial reporter is not a health professional, it is a distributor.Block g2: there was an error in the report source, the report was coming from a distributor.We apologize for these errors.Additional narrative: (10/3236) the returned device was visually inspected by the qa supervisor who confirmed that the shipping box was damaged and the product box was damaged.As a result, product is not compliant.Following this visual inspection, the qa manager concluded on the root cause of the event: "it is a problem due to the transportation." (4308) the most likely cause of this event is a problem due to the transportation.An internal non-conformity report has been initiated in order to take appropriate action.
Event or Problem Description
See mfg initial report 1640201-2021-00028.Complaint # (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: 12364781
• Report Number: 1640201-2021-00028
• Device Sequence Number: 14610758
• Product Code: MAL
• UDI-Device Identifier: 00384401018148
• UDI-Public: (01)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,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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: 05/31/2026
• Device Model Number: M00202175208P0
• Device Catalogue Number: M00202175208P0
• Device Lot Number: 21F02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/28/2021
• Patient Sequence Number: 1