MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTRAVIA; CONTAINER, I.V.

Model Number	2B8012
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an intravia container 250 ml capacity leaked from a tear on the side of the dosing port where the port tubing from the bag meets the port insert.This occurred prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Correction to e1: initial reporter first name and last name, e1: initial reporter address, previous h11 (remove "e1: initial reporter address: (b)(6)" and update to "e1: initial reporter address: (b)(6)").H11: the actual device was received for evaluation.Visual inspection of the actual sample did not identify any abnormalities that could have contributed to the reported condition.A pressure testing was performed on the sample, and it was noted that there was a leak between the injection site and the bag.The reported condition was verified.The cause of the condition is related to the manufacturing process.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 HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA; 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: 21080136
• Report Number: 1416980-2024-07822
• Device Sequence Number: 8386661
• Product Code: KPE
• UDI-Device Identifier: 00085412003191
• UDI-Public: (01)00085412003191(10)DR24G05109
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K964853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: Other
• Device Model Number: 2B8012
• Device Catalogue Number: 2B8012
• Device Lot Number: DR24G05109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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