MAUDE Adverse Event Report: THE METRIX COMPANY SECURE EVA 2-PORT BAG W/O LEGS 500ML; EVA 2-PORT BAG 500ML

Model Number	419-64050
Medical Device Problem Codes	Material Disintegration (1177); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two photos were provided by the customer.They both show the same emptied bag that appears to have been previously filled with a clear liquid.Both photos are of the back of the bag.A large circular particulate in the rough shape of a disc is located on the upper right corner from the back.The color and characteristics of the material appear to be similar to those inherent to the bag.It resembles the diaphragm of the spike port used in this product.No samples were received.The photos and description of the incident by the customer share similarities with a previous complaint.Samples were available for examination for that complaint, and it was concluded that the particulate was the diaphragm from the spike port that had dislodged during spiking.Based on these similarities, it appears the particulate in this present complaint might also be a dislodged diaphragm form the spike port.No information on user technique is known.The spike port in this device (m424) arrives at metrix fully formed.Integrity of the spike port in the affected bag is unknown.Without further information, the root cause is undetermined.
Event or Problem Description
The reported product involves one customer eva 2-port bag, 500 ml (64050-a8834).The customer reported that a healthcare provider (pharmacist) observed a circular-shaped particulate after filling the bag during routine validation and inspection for particulates.No product samples were available for evaluation; however, photographs were provided.There were no reports of patient involvement or adverse events.The reported product involves one customer eva 2-port bag, 500 ml (64050-a8834).The customer reported that a healthcare provider (pharmacist) observed a circular-shaped particulate after filling the bag during routine validation and inspection for particulates.No product samples were available for evaluation; however, photographs were provided.There were no reports of patient involvement or adverse events.

• Brand Name: SECURE EVA 2-PORT BAG W/O LEGS 500ML
• Common Device Name: EVA 2-PORT BAG 500ML
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle rd; dubuque IA 52001
• Manufacturer (Section G): METRIX DOMINICANA; parque industrial itabo; bldg 5; san cristobal
• Manufacturer Contact: patricia ayers ; 4400 chavenelle rd; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 24402704
• Report Number: 1937141-2025-00006
• Device Sequence Number: 15521249
• Product Code: KPE
• UDI-Device Identifier: 10612479272160
• UDI-Public: 10612479272160
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K030888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: 419-64050
• Device Catalogue Number: 419-64050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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