MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. INTRAVIA; CONTAINER, I.V.

Model Number	2J8002
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
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 two (2) 250ml non-dehp fluid path intravia containers had damaged ports resulting in medication to leak out.This occurred while removing the syringe and needle after injecting the medication into the injection port on a bag.The entire circular injection port came out of the intravia bag, leaving an open port.A second intravia bag was used to mix another bag of medication, and the injection port was able to be removed with the fingers only.A third bag was used to mix the medication properly.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: d4 expiration date (update to n/a), d9, h3, h4, h6, h11.H11: two (2) actual samples were received for evaluation.A visual inspection was performed using the naked eye which observed the injection ports were damaged and had roughness; however, the remaining components were placed according to specifications.The reported condition was verified.The cause of the condition could not be determined; however, a probable cause may be related to environmental conditions where the product was stored.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTRAVIA
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; piisa industrial park antigua; carretera sanchez km 18 1/2; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20327143
• Report Number: 1416980-2024-05328
• Device Sequence Number: 15361077
• Product Code: KPE
• UDI-Device Identifier: 00085412029573
• UDI-Public: (01)00085412029573(10)DR23I22062
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964853
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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: Other
• Device Model Number: 2J8002
• Device Catalogue Number: 2J8002
• Device Lot Number: DR23I22062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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