MAUDE Adverse Event Report: RIVERPOINT MEDICAL VELOSORB FAST; ABSORBABLE POLY(GLYCOLIDE/L-LACTIDE) SURGICAL SUTURE

Model Number SV935

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation.Device history records for the indicated production lot were reviewed and found to meet all product requirements prior to release.Product retains from the same lot were tested and found to pass all performance specifications, which included tensile strength and needle attachment testing.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.[(b)(4)].

Event Description

According to the reporter, "at the end of surgery for cesarean section, the needle and thread of the suture broke.There was no patient injury".

• Brand Name: VELOSORB FAST
• Type of Device: ABSORBABLE POLY(GLYCOLIDE/L-LACTIDE) SURGICAL SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave.; portland OR 97232
• Manufacturer (Section G): RIVERPOINT MEDICAL; 825 ne 25th ave; portland OR 97232
• Manufacturer Contact: edwin anderson ; 825 ne 25th ave; portland, OR 97232 ; 5035178001
• MDR Report Key: 8518782
• MDR Text Key: 146372232
• Report Number: 3006981798-2019-00004
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K120556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2021
• Device Model Number: SV935
• Device Catalogue Number: SV935
• Device Lot Number: 18052901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1