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	05/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bag was not returned to manufacturer.Photos were not available.Production records were reviewed.No abnormalities noted.Should additional relevant information become available, a supplemental report will be filed.
Event or Problem Description
Received report of lipid migration in dual chamber bag after transport to location of end use.Issue was discovered during inspection of bag prior to setting up for administration.There was no report of patient injury or medical intervention as a result of this event.The actual samples were discarded by the customer.No photographs have been provided for investigation.
Event or Problem Description
Update: in the original 1937141-2023-00018 submission, the box "congenital anomaly/birth defect" was inadvertently checked.There was no adverse event associated with this report.Original problem description: received report of lipid migration in dual chamber bag after transport to location of end use.Issue was discovered during inspection of bag prior to setting up for administration.There was no report of patient injury or medical intervention as a result of this event.The actual samples were discarded by the customer.No photographs have been provided for investigation.
Additional Manufacturer Narrative
Original submission of 1937141-2023-00018 contained an error in box b.2.There was no adverse event associated with this report.The box "congenital anomaly/birth defect was inadvertently checked.This follow-up submission is to correct that error.

• Brand Name: EXACTAMIX
• Common Device Name: 3000 ML EMPTY EVA DUAL CHAMBER BAG
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle rd; dubuque IA 52002
• Manufacturer (Section G): METRIX DOMINICANA; parque industrial itabo; building 5; san cristobal, dom ; DR
• Manufacturer Contact: nicholas specht ; 4400 chavenelle rd; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 17194901
• Report Number: 1937141-2023-00018
• Device Sequence Number: 5642844
• 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,Followup
• Report Date (Section B): 06/27/2023

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-A7575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2022
• 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
• Outcome Attributed to Adverse Event: Congenital Anomaly
• Patient Sex: Unknown