MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EVA DUAL CHAMBER CONTAINER 3L; CONTAINER, I.V.

Catalog Number	H938905
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 3000 ml dual-chamber eva (ethyl vinyl acetate) bag leaked from an unspecified location.This was identified before use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Initial reporter postal code: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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: EVA DUAL CHAMBER CONTAINER 3L
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): THE METRIX COMPANY; 4400 chavenelle road; kurralta park ; AS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16567906
• Report Number: 1416980-2023-01169
• Device Sequence Number: 12118326
• Product Code: KPE
• UDI-Device Identifier: 00085412477473
• UDI-Public: (01)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,Consumer,Company Representative
• Initial Reporter Occupation: Other
• 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 Expiration Date: 02/23/2023
• Device Catalogue Number: H938905
• Device Lot Number: 63630-A7060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 03/17/2023
• 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