MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; 250 ML 2 PORT EVA BAG

Model Number	66045
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample containing the particulate was not able to be returned for evaluation by the customer and the particulate was not able to be identified by the photos shared.The additive port was accessed for filling of the product and no particulate was identified by the customer prior to filling.The particulate identified could have been generated by inadvertent contact between the needle and the wall of the additive port.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
A customer reported "part of the bag floating inside the bag" post-compounding, after injection of the bag, of one sample.The product was filled by the pharmacy and was not available to be returned for evaluation.Images of the product were provided and no particulate could be visually identified.No additional information is available.

• Brand Name: SECURE
• Common Device Name: 250 ML 2 PORT EVA 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: 18773135
• Report Number: 1937141-2024-00002
• Device Sequence Number: 20758536
• Product Code: KPE
• UDI-Device Identifier: 00812496011589
• UDI-Public: 00812496011589
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2024

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: Lay User/Patient
• Device Expiration Date: 04/29/2025
• Device Model Number: 66045
• Device Catalogue Number: 66045
• Device Lot Number: A7690
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2022
• 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