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	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the particulates were identified within product prior to filling.The product was returned filled and evaluated.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that pharmacy technicians identified stock dilutions prepared in 100 ml secure empty bags with visible particulate.The report indicated the particulate matter identified resembled a circular plastic "floating" particle "in the bag solution prior to filling".Two samples were returned in a filled state, both samples had a non-vented dispensing pin inserted into the twist off administration port.One plastic circular particulate was identified in both of the bags returned for evaluation.Both circular particulates measured approximately 3/16" in diameter and were similar in appearance.As the particulate was identified in the pharmacy, there was no patient involvement.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, dom ; DR
• Manufacturer Contact: demitrianna soppe ; 4400 chavenelle road; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 17701798
• Report Number: 1937141-2023-00019
• Device Sequence Number: 20694589
• Product Code: KPE
• UDI-Device Identifier: 00812496011541
• UDI-Public: 00812496011541
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Company Representative
• 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: 04/13/2023
• Device Model Number: 66040
• Device Catalogue Number: 66040
• Device Lot Number: 66040-A8044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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