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	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a pharmacy technician that while filling a secure eva dual chamber 3000 ml bag, lot 66631-a6597, a small amount of lipids in the upper chamber prematurely migrated into the admixture of solutions in the lower chamber.There was no patient involvement.The unit was returned to metrix for evaluation.The results of the investigation are still pending.If additional relevant information becomes available, a supplemental report will be submitted.
Additional Manufacturer Narrative
G2: report source was corrected to indicate a foreign entity and health professional.H6: investigation findings and investigation conclusions were updated based on the results of the attached device evaluation and subsequent investigation.

• 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
• MDR Report Key: 11770308
• Report Number: 1937141-2021-00002
• Device Sequence Number: 14618331
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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 Model Number: 66631
• Device Catalogue Number: 66631
• Device Lot Number: 66631-A6597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1