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

Model Number	2B8013
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was particulate matter (pm) within two (2) intravia containers, empty 500 ml capacity.The pm was described as "floaters" found during the inspection process.The devices contained ampicillin/sulbactum 15gm constituted in 0.9% sodium chloride.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H11: the actual device and forty (40) companion samples were received for evaluation.Visual inspection was performed on the actual sample, and it was noted that there was a small particulate observed inside the bag.The reported condition was verified.The cause of the reported condition could not be determined; however, this particle appears to be detached from the membrane of the port due to the spiking process by the end user.Visual inspection on the companion samples did not identify any abnormalities that could have contributed to the reported condition.During sample analysis, no particulate was in the fluid and no particulate was found in the sample evaluated.The reported condition was not verified in the companion sample.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; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20176715
• Report Number: 1416980-2024-04867
• Device Sequence Number: 8723379
• Product Code: KPE
• UDI-Device Identifier: 00085412035260
• UDI-Public: (01)00085412035260(10)DR22B08062
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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: 2B8013
• Device Catalogue Number: 2B8013
• Device Lot Number: DR22B08062
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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