MAUDE Adverse Event Report: METRIX COMPANY, THE SECURE; CONTAINER, I.V.

Model Number	66225
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The cap of the secure empty eva bag is fused with the port of the bag.Unable to twist off the cap to fill.The intended procedure is to uncap the bag and connect it to the em2400 compounder to pump ingredients into.No patient involved.The damaged bag was found before use.

• Brand Name: SECURE
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): METRIX COMPANY, THE; 4400 chavenelle rd.; dubuque IA 52002
• MDR Report Key: 10835597
• Report Number: 10835597
• Device Sequence Number: 11661451
• Product Code: KPE
• UDI-Device Identifier: 00812496011725
• UDI-Public: (01)00812496011725
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 11/11/2020
• Report Date (Section F): 11/11/2020

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: 66225
• Device Catalogue Number: 66225
• Device Lot Number: A6753
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/11/2020