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

Model Number	AG730
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2016
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 the returned product and packaging verified that leakage occurred based on lower volume of liquid and smeared labeling.A root cause was not able to be identified for the complaint allegation of leaking tube as the returned product was received open with the tamper-evident seal and tube shrink wrap removed.When pressure was applied to the inverted tube no leaks occurred.There is no noticeable damage to the product tube, cap, or packaging.The device history record for batch 15h214 was re-reviewed and no related nonconformances were identified; the torque machine and capper were within specifications at the time of use and visual inspections and final visual inspections by 2 independent reviewers met the requirements at the time of release.To date, no additional complaints were reported from this product batch.No complaint trends were identified for the issue of leaking tube.The complaint issue will continue to be monitored within artegraft, inc.Quality systems, quality assurance trending.
Event or Problem Description
Artegraft (collagen vascular graft) lot 15h214-004 was received in the mail with a packing slip from (b)(4) (artegraft approved distributor) stating that on (b)(6) 2015 a rn went to open the tube and the seal was leaking, so didn't feel comfortable using it.It also states that the box was sealed.A second artegraft (collagen vascular graft) was utilized on the patient instead.No patient adverse events 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: 5914110
• Report Number: 2247686-2016-00009
• Device Sequence Number: 18836808
• Product Code: LXA
• UDI-Device Identifier: 00316837000275
• UDI-Public: (01)00316837000275(17)180831(10)15H214-004
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N16837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/05/2016

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: Nurse
• Device Expiration Date: 08/31/2018
• Device Model Number: AG730
• Device Catalogue Number: AG730
• Device Lot Number: 15H214-004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2016
• Initial Report FDA Received Date: 08/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1