MAUDE Adverse Event Report: RIVERPOINT MEDICAL SUTUP; SUTURE

Model Number	HS959-MU
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the dhr showed that the product and packaging were visually inspected per finished goods testing requirements prior to release and no issues were noted.
Event or Problem Description
According to the reporter, "after opened the box in surgery we have detected a cut on the bag.".

• Brand Name: SUTUP
• Common Device Name: SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave.; portland OR 97232
• MDR Report Key: 9321862
• Report Number: 3006981798-2019-00012
• Device Sequence Number: 16860554
• Product Code: GAT
• UDI-Device Identifier: 00812444027013
• UDI-Public: 00812444027013
• Combination Product (Y/N): N
• PMA/510(K) Number: K100006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

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: No Information
• Device Expiration Date: 03/31/2024
• Device Model Number: HS959-MU
• Device Lot Number: 19040329
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1