MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC VELOSORB FAST; SUTURE

Model Number	SV2297
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.A review of the dhr for the lot was performed and no issues were noted during manufacturing.Retain samples from the same lot were tested for finished goods testing, including suture tensile strength and needle attachment testing.Test results show that all retain samples passed.Investigations performed did not reveal any issues with the product and the report could not be substantiated.If additional information is provided to riverpoint medical regarding this event, a supplementary 3500a form will be submitted as required by the fda.
Event or Problem Description
According to the reporter, "the needle came loose of the suture.".

• Brand Name: VELOSORB FAST
• Common Device Name: SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer (Section G): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer Contact: amanda cole ; 825 ne 25th ave; portland, OR 97232 ; 5035178001
• MDR Report Key: 12812533
• Report Number: 3006981798-2021-00028
• Device Sequence Number: 11956566
• Product Code: GAM
• UDI-Device Identifier: 20884521150956
• UDI-Public: 20884521150956
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

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
• Device Expiration Date: 05/31/2024
• Device Model Number: SV2297
• Device Lot Number: 21061511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown