MAUDE Adverse Event Report: THE METRIX COMPANY CORMIX; EMPTY EVA CONTAINER WITH FEMALE SCREW CONNECTOR

Model Number	MS64230
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the product sample nor images of the particulate identified by the customer for this event were provided by the customer for evaluation.A review of production records and environment was completed for the product lot and no root cause could be determined.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
Customer found "plastic floating in the bag after mixing a tpn" during inspection of the product by a healthcare provider.The product was not being administered, and there was no patient involvement.The sample was not available for evaluation.No additional information is available.

• Brand Name: CORMIX
• Common Device Name: EMPTY EVA CONTAINER WITH FEMALE SCREW CONNECTOR
• 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
• MDR Report Key: 18996047
• Report Number: 1937141-2024-00003
• Device Sequence Number: 2997648
• Product Code: KPE
• UDI-Device Identifier: 00812496011268
• UDI-Public: 00812496011268
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/20/2024

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: Health Professional
• Device Model Number: MS64230
• Device Catalogue Number: MS64230
• Device Lot Number: 64230-A8040
• 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: 03/04/2024
• Initial Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2023
• 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