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

Catalog Number	2B8013
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	01/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility submitted medwatch mw5114862 for this event.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the port from two (2) 500 ml intravia containers completely dislodged from the bag resulting in a leak of the medication.The issue was identified when pulling the blue stopper (tip protector) from the bags.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: two (2) actual samples were received for evaluation.Upon visual inspection, one device was received with a detached bag membrane port.In addition, a loose spike from a tubing set (non-baxter product ) was stuck into the detached membrane port.A visual inspection was performed to the two (2) samples and also to the spike stuck into the detached membrane port.On one of the devices, a separation between the tip port (where the membrane port attaches to the bag) and the membrane port of the bag was observed.No issues were visually observed on the other sample.Functional tests which included under water pressure test, solvent wet test and the minimum insertion tests were performed on both samples and the results were satisfactory.Therefore, the reported condition was not verified on one of the samples, however, was verified on the other.The cause of the condition could not be determined, however, a probable cause was user related due to the type of spike used to access the bag port based on the spike size used and the resulting friction upon removing the spike.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 CONTAINER EMPTY
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 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: 16546146
• Report Number: 1416980-2023-01081
• Device Sequence Number: 17760282
• Product Code: KPE
• UDI-Device Identifier: 00085412035260
• UDI-Public: (01)00085412035260
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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: Health Professional
• Device Catalogue Number: 2B8013
• Device Lot Number: DR22H18093
• 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: 02/17/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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