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

Model Number	SV-6830
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Velosorb product were labeled as non-sterile and intended for shipment to the contract sterilizer but were inadvertently shipped to the distributor.Riverpoint placed an immediate hold on manufacturing and distribution of the velosorb product and a device recall (z-0016-2021).Corrective actions were taken by riverpoint to prevent incorrect shipping of non-sterile product.This report and use of categorical definitions required by fda 3500a does not constitute an admission by riverpoint medical, or its employees, that riverpoint medical or its employees have caused or contributed to the event described in this report.Riverpoint medical has filed this information to comply with the medical device reporting regulation 21 cfr part 803.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
Velosorb products were labeled as non-sterile and intended for shipment to the contract sterilizer but were inadvertently shipped to the distributor.Products were further distributed to customers.Riverpoint placed an immediate hold on manufacturing and distribution of the velosorb product and device recall z-0016-2021 was initiated.

• Brand Name: VELOSORB FAST
• Common Device Name: SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• MDR Report Key: 12368169
• Report Number: 3006981798-2021-00014
• Device Sequence Number: 3793974
• Product Code: GAM
• UDI-Device Identifier: 20884521152349
• UDI-Public: 20884521152349
• Combination Product (Y/N): N
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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: 04/30/2023
• Device Model Number: SV-6830
• Device Lot Number: 20051814FX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0016-2021
• Patient Sequence Number: 1