MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; 100ML 2 PORT EVA 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	07/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported the pharmacist noticed a floating particulate within two products of the same lot.The customer reported the particulate resembled "a plastic thread in the iv bag".The product samples were not available for return by the customer.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that particulate was identified within two product samples of product 66040 by the pharmacy during inspection after filling the bags.The customer reported the bags were discarded by the pharmacy and are not available for evaluation.There was no patient involvement.No additional information is available.

• Brand Name: SECURE
• Common Device Name: 100ML 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, dom ; DR
• Manufacturer Contact: demitrianna soppe ; 4400 chavenelle road; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 17703565
• Report Number: 1937141-2023-00020
• Device Sequence Number: 20519708
• Product Code: KPE
• UDI-Device Identifier: 00812496011541
• UDI-Public: 00812496011541
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/05/2023

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: Health Professional
• Device Expiration Date: 08/22/2025
• Device Model Number: 66040
• Device Catalogue Number: 66040
• Device Lot Number: A7774
• 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: Not provided
• Initial Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2022
• 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