MAUDE Adverse Event Report: THE METRIX COMPANY SECURE®; EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET (8 SETS OF 5 BAGS

Model Number	66631
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Small tear at separator bar inseam that resulted in a leak.It was indicated by personnel there was no indicator of leak at time of filling or several bag inspections.Upon removal of separator bar, tear was apparent and bag leaked.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be filed.

• Brand Name: SECURE®
• Common Device Name: EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET (8 SETS OF 5 BAGS
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle rd.; dubuque IA 52002 2655
• Manufacturer (Section G): METRIX DOMINICANA; parque industrial itabo; building 5; san cristobal, dom ; DR
• Manufacturer Contact: shawn edwards ; 4400 chavenelle rd.; dubuque, IA 52002-2655
• MDR Report Key: 17147820
• Report Number: 1937141-2023-00017
• Device Sequence Number: 5421485
• Product Code: KPE
• UDI-Device Identifier: 20812496011514
• UDI-Public: 20812496011514
• Combination Product (Y/N): Y
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2023

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-A8010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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