MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC PLAIN GUT; STERILE, COLLAGEN ABSORBABLE SUTURE

Model Number	5257620
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was returned for evaluation.Production records were reviewed.During the review of the dhr, po, bom, and customer specifications, it was identified that the riverpoint part number data set in the system is linked to the po, whereas the data in the labeling erp system is linked to the customer specification.Additionally, the information of the riverpoint part number in the po and the customer specification for both part numbers appears to be swapped.The customer reference is consistent across all the documents reviewed.Due to this configuration error, improper label kitting was done from labeling system.There were no nonconformities noted with the lot during production.All finished goods testing requirements were met prior to release.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 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, "i need to open a complaint regarding lot number 250421652.I believe the label is incorrect.We shipped lot number 250421652 against dar-pg535, when you look this lot up in the transaction log, it references dar-pg686.We have only placed 2 orders for our item #5257620: 51390005 - 6 pcs.( not 10 as noted on your email) 51390018- 10 pcs." darby item number: riverpoint item number: item description: 5257620, dar-pg535 , plain gut, 5-0, 18", c-3, 5257626 , dar-pg686, plain gut, 5-0, 18", p-3.

• Brand Name: PLAIN GUT
• Common Device Name: STERILE, COLLAGEN ABSORBABLE 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: edwin anderson ; 825 ne 25th ave; portland,, OR 97232
• MDR Report Key: 22676864
• Report Number: 3006981798-2025-00028
• Device Sequence Number: 15868928
• Product Code: GAL
• UDI-Device Identifier: 00889813064726
• UDI-Public: 00889813064726
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K001299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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 Model Number: 5257620
• Device Lot Number: 250421652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• 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