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	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Examination of the returned sample showed the leak did not originate from the seal area.A slit was noted on the face of the bag near the seal area.As the leak was not detected during the filling process nor during unpacking at the user's home, it is believed the bag made contact with a sharp surface during user handling.Should additional relevant information become available, a supplemental report will be filed.
Event or Problem Description
Customer advised the parents of a home patient reported one compounded parenteral nutrition bag leaking approximately 2 hours into the infusion.The end user reported the bag leaked on the side where the two edges of the bag join.The patient was at home in bed during the infusion and there was no skin contact with the parenteral nutrition solution.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: jennifer clasen ; 4400 chavenelle road; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 15374403
• Report Number: 1937141-2022-00008
• Device Sequence Number: 14809884
• 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): 09/07/2022

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: 09/15/2026
• Device Model Number: H938905
• Device Catalogue Number: H938905
• Device Lot Number: 63630-A7049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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