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

Catalog Number	2B8013
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a 500ml intravia container was leaking from the seal around both sides of the port.It was not specified when in the process step this occurred.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: the device was received for evaluation.Visual inspection was performed using naked eye and all components are correctly placed and according to the specification.Functional test were performed by submerging the device in water and as a result, bubbles were observed coming from between the outside side of the injection site port tube and the top of the port/flat seal.The reported condition was verified.The cause of the condition was due 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 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: 15928795
• Report Number: 1416980-2022-06677
• Device Sequence Number: 6797932
• Product Code: KPE
• UDI-Device Identifier: 00085412035260
• UDI-Public: (01)00085412035260
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: Other
• Device Catalogue Number: 2B8013
• Device Lot Number: DR22E04031
• 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: 11/10/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED FLUID
• Patient Sex: Female