MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC UMBILICAP TAPE; STERILE, NON ABSORBABLE SURGICAL COTTON

Model Number	CP-12A
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, "this pack contained qty (b)(4) component of cp-12a.Should only have qty (b)(4) of these components in the kit.".
Additional Manufacturer Narrative
The device was not returned.Production records were reviewed.The customer reported that they received one packet of p/n: cp-12a, lot: 250408226 that contained four units rather than three.There was no further information available and the product was not returned.Upon investigation into the production process, it was discovered that the internal specification document (ps-ut0001) was not followed.Quality alert crc-056-2025 was issued to reinforce adherence to this specification.There was no evidence that the device failed to meet specifications and the issue is limited to an additional device present in the pack.This issue will continue to be trended and monitored.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 has cause or contributed to the event described in the report.Riverpoint medical 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 fda.

• Brand Name: UMBILICAP TAPE
• Common Device Name: STERILE, NON ABSORBABLE SURGICAL COTTON
• 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: 23934754
• Report Number: 3006981798-2025-00056
• Device Sequence Number: 18503703
• Product Code: EXM
• UDI-Device Identifier: 00840277405814
• UDI-Public: 00840277405814
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

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: CP-12A
• Device Lot Number: 250408226
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2025
• 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