MAUDE Adverse Event Report: RIVERPOINT MEDICAL RIVERLON; SUTURE, NONABSORBABLE, POLYAMIDE

Model Number	928BK
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Riverpoint medical has received feedback from a convenience kit packer that product seals may become open during distribution or subsequent packaging.A riverpoint internal investigation found that the product listed above may intermittently become open during extreme distribution conditions and render the device unsterile.To date there have been no complaints or adverse effect noted during surgical use of the device.
Event or Problem Description
Riverpoint medical has received feedback from a convenience kit packer that product seals may become open during distribution or subsequent packaging.

• Brand Name: RIVERLON
• Common Device Name: SUTURE, NONABSORBABLE, POLYAMIDE
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th avenue; portland OR 97232
• MDR Report Key: 5937281
• Report Number: 3006981798-2016-00001
• Device Sequence Number: 10852578
• Product Code: GAR
• UDI-Device Identifier: 10812444024316
• UDI-Public: (01)10812444024316(17)210131(10)16020401
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K100006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/16/2016

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: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 928BK
• Device Lot Number: 160204-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2016
• Initial Report FDA Received Date: 09/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1