MAUDE Adverse Event Report: THE METRIX COMPANY EXACTAMIX; 1500 ML EMPTY EVA DUAL CHAMBER BAG

Model Number	H938901
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that 1 sample of compounded product was identified with a leak by the end user prior to use.Details state, "when they went to cut open the bag, they lifted the bag still in silver over pouch and they noticed fluid leaking out of the 2 small air holes of the over pouch.When they cut it open and took out the bag on their bench, they noticed the bag leak was quite severe.What they found was the bar that separates the 2 sections, there was a split right next to the separation bar on the side of the yellow liquid".The customer was wearing gloves while handling the sample and no skin contact was reported.There was no report of patient injury or medical intervention as a result of this event.The sample was discarded by the customer.Images of the sample were provided but no leak location was identified.The customer stated that the overpouch and external packaging carton did not appear damaged.No additional information is available.
Additional Manufacturer Narrative
The customer reported a leak identified "right next to the separation bar on the right side of the yellow liquid".Images were provided but the leak location was not able to be identified.The sample was not available for return.Component inspection records, production records, and tooling and machine validations were reviewed for the lot and no nonconformances, deviations, or abnormalities were identified.Due to the lack of sample availability and limited information provided regarding the leak location, a root cause could not be determined.Should additional information become available, a supplemental report will be provided.

• 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, dom ; DR
• Manufacturer Contact: demitrianna soppe ; 4400 chavenelle road; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 19217501
• Report Number: 1937141-2024-00007
• Device Sequence Number: 8241571
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2024

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: H938901
• Device Catalogue Number: H938901
• Device Lot Number: A7576
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2024
• 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