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

Model Number	CV-917
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.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.No cause of the event could be established and the report could not be substantiated.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
According to the reporter, "at the end of suturing in a episiotomy, the needle and thread detached.The needle was found to continue the case.There was no patient injury.".

• Brand Name: VELOSORB FAST
• Common Device Name: SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• MDR Report Key: 12204721
• Report Number: 3006981798-2021-00007
• Device Sequence Number: 16514113
• Product Code: GAM
• UDI-Device Identifier: 20884521151656
• UDI-Public: 20884521151656
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2021

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: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: CV-917
• Device Lot Number: 20050515X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1