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

Catalog Number	2J8003
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	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 500 ml capacity non-dehp fluid path intravia container leaked at the administration port when it was spiked by the nurse.This was discovered during set-up and preparation.Upon further inspection, a part of the administration port was missing (detached).There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
E1: additional initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: the actual device was not available; however, photographs of the sample were provided for evaluation.A visual inspection of the photographs with the naked eye observed that the device was missing the membrane tube of the administration port.Due to the nature of the sample, no additional tests could be performed.The reported condition was verified.The cause of the condition could not be determined.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: 17965716
• Report Number: 1416980-2023-05325
• Device Sequence Number: 12680209
• Product Code: KPE
• UDI-Device Identifier: 00085412029566
• UDI-Public: (01)00085412029566
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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: 2J8003
• Device Lot Number: DR22K25130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2022
• 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