MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX EVA DUAL CHAMBER MIXING BAG; CONTAINER, I.V.

Catalog Number	H938901
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a 1500 ml dual-chamber eva (ethyl vinyl acetate) bag had a pinhole leak in the lipid phase section of the bag.This was identified after compounding, but before release.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Upon further review, baxter is not the manufacturer of this product and does not have reporting responsibility for this product.If needed, the manufacturer will submit any required regulatory submissions for this event to the fda.

• Brand Name: EXACTAMIX EVA DUAL CHAMBER MIXING BAG
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): THE METRIX COMPANY; 4400 chavenelle road; dubuque IA 52002
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16534737
• Report Number: 1416980-2023-01035
• Device Sequence Number: 17640522
• Product Code: KPE
• UDI-Device Identifier: 00085412477466
• UDI-Public: (01)00085412477466
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2023

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: Other
• Device Catalogue Number: H938901
• Device Lot Number: 63615-A7568
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 03/22/2023
• 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