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	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample was discarded by the customer.No photographs of the sample were available.The customer could not confirm the bag lot number.Should additional relevant information become available, a supplemental report will be provided.
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 leak was not contained to the overpouch and bag contents spilled on to a contact surface.The patient reported skin contact with the solution.No report of patient injury or medical intervention was reported as a result of this event.The patient was unable to determine the source of the leak.No photos, sample, or lot number of the impacted sample were available for review.No additional information is available at this time.

• 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; san cristobal, dom ; DR
• Manufacturer Contact: demitrianna soppe ; 4400 chavenelle road; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 19579492
• Report Number: 1937141-2024-00009
• Device Sequence Number: 3943965
• 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): 06/20/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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