MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS DURA-GUARD; DURA SUBSTITUTE

Catalog Number	DG1016SN
Medical Device Problem Codes	Fluid/Blood Leak (1250); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that lids on three (3) dura-gard patch containers were crooked, which resulted in leakage.The crooked lids were discovered during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The actual devices were not available; however, photographs of the samples were provided for evaluation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A visual examination of the photographs was performed which indicated that the lids had popped off of the jars.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: DURA-GUARD
• Common Device Name: DURA SUBSTITUTE
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; saint paul MN
• MDR Report Key: 8197782
• Report Number: 1416980-2018-08013
• Device Sequence Number: 1694141
• Product Code: GXQ
• UDI-Device Identifier: 00085412531045
• UDI-Public: (01)00085412531045
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K982282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2019

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: Health Professional
• Device Expiration Date: 08/01/2023
• Device Catalogue Number: DG1016SN
• Device Lot Number: SP18J25-1332679
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1