MAUDE Adverse Event Report: ARTEGRAFT,INC. ARTEGRAFT; COLLAGEN VASCULAR GRAFT

Model Number	AG740
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is deemed to be a reportable malfunction as it is uncertain whether the integrity of the sterile package may have been compromised.The investigation of returned product artegraft (collagen vascular graft) lot number 15h217-002 verified that leakage had occurred but was unable to identify a root cause for the complaint allegation of leaking tube as the returned product was received open.When pressure was applied to the upside down tube no leaks occurred.There was no noticeable damage to the tube or cap.The color of the liquid in the tube should be clear but was tinted yellow and dried brown residue was observed on the tube cap, which may imply that the product was tampered with at the customer site after the shrink wrap was removed from the product tube.The device history record for batch 15h217 was re-reviewed and no related nonconformances were identified; the in-process torque capping machine was within specifications at the time of use and visual inspections and final visual inspections by 2 independent reviews met the requirements at the time of release.No confirmed complaint trends were identified for the issues of leaking tube.To date, no additional complaints were reported from this product batch.The complaint issue will continue to be monitored within artegraft, inc.Quality systems, quality assurance trending.Should additional information become available, a follow-up report will be submitted.
Event or Problem Description
Artegraft, inc.Received an email from an authorized distributor stating, "had a customer open a graft to be implanted and some of the sterile solution had leaked out of the bottle prior to being opened." the complaint graft (lot 15h217-002) was not utilized.The procedure was completed with another artegraft (collagen vascular graft).No patient adverse events related to this issue were reported.

• Brand Name: ARTEGRAFT
• Common Device Name: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT,INC.; 206 north center drive; north brunswick NJ 08902 4247
• MDR Report Key: 6406072
• Report Number: 2247686-2017-00001
• Device Sequence Number: 13528786
• Product Code: LXA
• UDI-Device Identifier: 00316837000299
• UDI-Public: (01)00316837000299(17)180930(10)15H217-002
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: N16837
• 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): 02/14/2017

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: 09/30/2018
• Device Model Number: AG740
• Device Catalogue Number: AG740
• Device Lot Number: 15H217-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1