MAUDE Adverse Event Report: RIVERPOINT MEDICAL VELOSORB FAST; SUTURE

Model Number	CV-9590
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned by the end user.A dhr review was performed and the lot was found to meet all requirements during manufacturing, including all finished goods testing.An investigation was initiated and retained samples from the lot were tested.The retain samples demonstrated reduced tensile strength.A capa and product removal was initiated.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, "during a childbirth episiotomy, after the first knot, the thread broke.The user changed the needle thread combination to complete the case.There was no patient injury.".

• Brand Name: VELOSORB FAST
• Common Device Name: SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave; portland OR 97232
• MDR Report Key: 10997641
• Report Number: 3006981798-2020-00010
• Device Sequence Number: 4242444
• Product Code: GAM
• UDI-Device Identifier: 20884521151304
• UDI-Public: 20884521151304
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/11/2020

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: 05/31/2022
• Device Model Number: CV-9590
• Device Lot Number: 19062715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1