MAUDE Adverse Event Report: THE METRIX COMPANY EXACTAMIX; BAXTER H938905 3000ML EVA DUAL CHAMBER

Model Number	H938905
Medical Device Problem Codes	Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample reported that was identified with leaking was discarded by the end user.No photographs of the sample were available for evaluation.The customer could not confirm contact information of the initial reporter, information regarding the leak description and location on the product, or any supplemental information regarding the reported event.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
A customer reported, "1 compounded parenteral nutrition bag was leaking.Customer reported the origin of leak was a "small split in it at the very top".The tear was in the central section of the smof chamber just above the sticker.There was no tear noticed on the outer bag.This was discovered when the nurses were preparing it the previous afternoon.No batch number was recorded and the bag was not kept or photographed." the customer confirmed there was no skin contact with any spilled contents and no injury or medical intervention as a result of this event.The customer stated that the overpouch and external packaging carton did not appear to be damaged.No additional information is available.

• Brand Name: EXACTAMIX
• Common Device Name: BAXTER H938905 3000ML EVA DUAL CHAMBER
• 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: demitrianna soppe ; 4400 chavenelle road; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 21219289
• Report Number: 1937141-2024-00014
• Device Sequence Number: 3568802
• Product Code: KPE
• UDI-Device Identifier: 00085412477473
• UDI-Public: 00085412477473
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 01/23/2025

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: Health Professional
• Device Model Number: H938905
• Device Catalogue Number: H938905
• Device Lot Number: A8093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2024
• 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