MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Model Number	M002020851260
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The involved product was returned to intervascular and was inspected by our quality assurance (qa) manager for an evaluation of the packaging components.His observations are as follows: one tamper-evident labels on the product box is opened.There is a match between the labeling of the box, the patient labels and the graft sizer inside.However, the product in the primary packaging and its labeling (model # m002020952120, lot # 25081421) do not correspond to the external box labeling.In conclusion, the product does not comply with the specifications due to a labeling discrepancy.The graft corresponding to the product box labeling was manufactured on september 2017 by intervascular sas in (b)(6), it was delivered to (b)(6) medical center on january 2018.The graft in the primary packaging that was found inside the product box was manufactured on july 2013 by maquet cardiovascular llc in the united states and was delivered to (b)(6) medical center on march 2014.Therefore, it is assumed that the packaging transfer occurred during storage at the hospital.The most likely cause of this event is a packaging mix-up during storage at the hospital.
Event or Problem Description
It was reported that the graft inside the product box did not match the box labeling.The product was never opened or implanted.

• Brand Name: HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 8707774
• Report Number: 1640201-2019-00033
• Device Sequence Number: 16642513
• Product Code: MAL
• UDI-Device Identifier: 00384401017684
• UDI-Public: 00384401017684
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: K954848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

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: No Information
• Device Expiration Date: 08/31/2022
• Device Model Number: M002020851260
• Device Catalogue Number: M002020851260
• Device Lot Number: 17J13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1