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	07/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A home parenteral nutrition patient's father reported that one unit of a compounded parenteral nutrition (pn) bag was found to be leaking on delivery.The leak was identified prior to use.The customer confirmed that the shipping carton was wet and that skin contact occurred with the parenteral nutrition solution.The customer stated "someone picked up carton and brought inside home, and found liquid inside the carton.Hand was washed with soap.Leaking bag was discarded after taking photos".There was no report of injury or medical intervention as a result of this event.No additional information is available.
Additional Manufacturer Narrative
Photographs were provided but the device itself was not visible.The photographs taken were of the interior of the shipping container with the device still enclosed in the light protective overpouch.Should additional relevant information become available, a supplemental report will be filed.

• 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: 15199822
• Report Number: 1937141-2022-00007
• Device Sequence Number: 14711023
• 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): 08/10/2022

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 Expiration Date: 09/22/2026
• Device Model Number: H938901
• Device Catalogue Number: H938901
• Device Lot Number: 63615-A7050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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