MAUDE Adverse Event Report: RIVERPOINT MEDICAL MAXIMA PTFE; SUTURE

Model Number	T8698
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record was performed and all products tested met finished goods testing requirements for the lot prior to release.Retained samples from the same lot were tested for needle attachment strength and tensile strength and all samples passed.The report could not be substantiated and a cause of the event could not be established.
Event or Problem Description
According to the reporter, "there was no harm or injury to patient.I do not have any more specifics to the complaint other than they used 4 packs and they kept breaking.".

• Brand Name: MAXIMA PTFE
• Common Device Name: SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave; portland OR 97232
• MDR Report Key: 11565901
• Report Number: 3006981798-2021-00003
• Device Sequence Number: 2955835
• Product Code: NBY
• UDI-Device Identifier: 00304040001257
• UDI-Public: 00304040001257
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

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: 07/31/2025
• Device Model Number: T8698
• Device Lot Number: 20081809
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1