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

Model Number	M002020851680
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A capa has been initiated in order to take appropriate actions.
Event or Problem Description
Customer ordered part number m002020851680 lot:21b10 sn: (b)(4).Upon arrival, outside packaging was labeled m002020851680.However, inside the box was m002020952070 lot:21b10 sn:(b)(4).According to initial information provided by the customer on september 22, 2021 : "my colleague confiscated graft: m002020952070 lot:21b10 sn: (b)(4) due to an potential patient safety issue.An rn approached him explaining she identified graft m002020952070 lot:21b10 sn:(b)(4).Inside a package labeled for m002020851680 (130529) lot:21b10 sn:1(b)(4).Graft: m002020952070 lot:21b10 sn: (b)(4) is not part of our par level and based on our inventory management system has never been ordered.Pro-active safety measures were performed by inspecting all other hemashield grafts stocked within the vascular core ¿ nothing more was identified.I¿ve attached an image of the product for your reference, please reach out should you have any further questions/concerns." (b)(4).
Additional Manufacturer Narrative
(10/4245) the involved product was received on january 17, 2022 and was visually inspected by the qa manager on 17-jan-2022.His observations are as follows: "the anti-humidity pocket has not been opened, the product is intact.On the other hand: - the labeling of the external box is identical to the patient set but is different from the internal box.- the product contained in the blister is a straight graft with a diameter of 7mm and a length of 60cm whereas the product reference indicated on the box and the patient set is a bifurcated graft 16 x 8mm.The product is therefore non-compliant.The product is physically rejected." a recall was initiated on january 4, 2022 to withdraw two inverted products from the market.One mislabeled product is located in the us (corresponding to complaint #(b)(4)- mfg report number 1640201-2021-00034).One mislabeled product is located in china (corresponding to this complaint #(b)(4) - mfg report number 1640201-2021-00026).
Event or Problem Description
Complaint # (b)(4).See mfg report number 1640201-2021-00034.

• Brand Name: HEMASHIELD GOLD KNITTED BIFURCATED
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer Contact: philip gaillard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 12638005
• Report Number: 1640201-2021-00034
• Device Sequence Number: 17229327
• Product Code: MAL
• UDI-Device Identifier: 00384401017721
• UDI-Public: (01)00384401017721
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: 01/31/2026
• Device Model Number: M002020851680
• Device Catalogue Number: M002020851680
• Device Lot Number: 21B10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown