MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; 3000 ML EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET

Model Number	66631
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned with the upper chamber partially filled and the lower chamber empty.A particulate was found to be adhered to the inner surface of the film in the upper chamber of the bag in the area indicated by the customer.The particulate was found to be partially disintegrated within the solution thus preventing further analysis.The customer has previously confirmed filtration is not utilized during the filling of the lipid chamber.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a mark that cannot be removed was present on the lipid chamber of a secure eva 3000 ml dual chamber bag.This was noted by the pharmacy filling staff during mixing.There was no patient involvement.No additional information is available.

• Brand Name: SECURE
• Common Device Name: 3000 ML EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET
• 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: jennifer clasen ; 4400 chavenelle road; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 16407604
• Report Number: 1937141-2023-00001
• Device Sequence Number: 6201039
• Product Code: KPE
• UDI-Device Identifier: 20812496011514
• UDI-Public: 20812496011514
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K960581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2023

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: Other
• Device Model Number: 66631
• Device Catalogue Number: 66631
• Device Lot Number: 66631-A7239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• 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