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

Model Number	H938905
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample indicated by this event was not available for evaluation.A leak location, images of the failure, and the sample were not available for evaluation.Should additional relevant information become available, a supplemental report will be filed.
Event or Problem Description
The customer reported that one sample of total parenteral nutrition (tpn) bag product 63630 was identified with a leak prior to use by the end user.The customer reported that the bag was identified as leaking within the overpouch packaging and discarded with no sample evaluation or images provided.There was no report of patient injury or medical intervention as a result of this event.No additional information is available.

• 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: demitrianna soppe ; 4400 chavenelle road; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 19365831
• Report Number: 1937141-2024-00008
• Device Sequence Number: 12347668
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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: Lay User/Patient
• Device Model Number: H938905
• Device Catalogue Number: H938905
• Device Lot Number: A7582
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2023
• 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