MAUDE Adverse Event Report: THE METRIX COMPANY EXACTAMIX; 1500 ML EMPTY EVA DUAL CHAMBER BAG

Model Number	H938901
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pharmacy label on the returned unit indicated the compounded volume was 1675 ml.The total capacity of the bag is 1500 ml.No abnormalities were noted during a batch record review.Should additional relevant information become available, a supplemental report will be filed.
Event or Problem Description
Customer advised one unit of a compounded bag was found to be leaking at a patient's home prior to use.There was no report of patient injury or medical intervention nor was there any report of skin contact with spilled parenteral nutrition as a result of this event.No additional information is available.

• Brand Name: EXACTAMIX
• Common Device Name: 1500 ML EMPTY EVA DUAL CHAMBER 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, ; DR
• Manufacturer Contact: jennifer clasen ; 4400 chavenelle road; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 15571204
• Report Number: 1937141-2022-00009
• Device Sequence Number: 2796927
• Product Code: KPE
• UDI-Device Identifier: 00085412477466
• UDI-Public: 00085412477466
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Foreign,Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2022

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: Lay User/Patient
• Device Model Number: H938901
• Device Catalogue Number: H938901
• Device Lot Number: 63615-A7059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• 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