MAUDE Adverse Event Report: THE METRIX COMPANY EXACTAMIX; 3000 ML EMPTY EVA DUAL CHAMBER BAG

Model Number	H938905
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that a patient identified a leak in two parenteral nutrition bags at their home prior to use.The customer further reported "patient reported they noticed that 2 bags were leaking; however could not identify the location of the leaks.Patient had already disposed of the bags and could not retrieve them for a photo." the customer was unable to obtain information from the patient regarding if any skin contact with the spilled solution had occurred nor if any damage was observed to the product packaging.There was no report of patient injury or medical intervention as a result of this event.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be filed.

• Brand Name: EXACTAMIX
• Common Device Name: 3000 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: 16644166
• Report Number: 1937141-2023-00015
• Device Sequence Number: 20181676
• Product Code: KPE
• UDI-Device Identifier: 00085412477473
• UDI-Public: 00085412477473
• 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): 03/30/2023

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: Lay User/Patient
• Device Model Number: H938905
• Device Catalogue Number: H938905
• Device Lot Number: 63630-A7565
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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