MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; 100 ML EVA LEGLESS 2 PORT BAG

Model Number	66040
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Metrix received medwatch report mw5170082 regarding the presence of a particulate in product 66040.The returned sample was analyzed, and the particulate was visually consistent with the twist-off port diaphragm material.The specific spike insertion technique and the condition of the diaphragm prior to spiking are unknown.Inspection records for the lot of twist-off ports used in manufacturing were acceptable, with no pre-use defects identified.A three-year review of similar field events revealed no trends.The most probable root cause is diaphragm dislodgement during spike insertion.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
A clear plastic particulate was observed by a health professional in a secure 100 ml empty eva container used to compound and infuse a 7-day dose of blinatumomab.The issue was discovered by the nurse upon disconnecting the completed infusion from the patient.The particle appeared visually similar in color and texture to the bag material.Local investigation ruled out compounding tools and tubing as the source due to the particle's size and color.No patient harm was reported.Photographs of the issue were provided.The device was returned for evaluation to the manufacturer.No additional information is available.

• Brand Name: SECURE
• Common Device Name: 100 ML EVA LEGLESS 2 PORT BAG
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle road; dubuque IA 52002
• Manufacturer (Section G): METRIX DOMINICANA; parque industrial itabo; building 5; san cristobal ; DR
• Manufacturer Contact: demitrianna soppe ; 4400 chavenelle road; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 22115755
• Report Number: 1937141-2025-00002
• Device Sequence Number: 4171682
• Product Code: KPE
• UDI-Device Identifier: 00812496011541
• UDI-Public: 00812496011541
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K03088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/29/2025

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: 66040
• Device Catalogue Number: 66040
• Device Lot Number: A8314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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