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

Catalog Number	2J8002
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the septum came out from the injection port of a non-dehp fluid path intravia container 250 ml capacity.The issue was identified before use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h3, h6 and h10.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph was performed using the naked eye which revealed damage (roughness) in the injection site.Due to the nature of the sample, no additional tests were performed.The reported condition was verified. the cause of the condition could not be determined; however the most probable cause is related to storage (environmental conditions). 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 ; 2242702068
• MDR Report Key: 13967171
• Report Number: 1416980-2022-01455
• Device Sequence Number: 4177033
• Product Code: KPE
• UDI-Device Identifier: 00085412029573
• UDI-Public: (01)00085412029573
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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 Expiration Date: 08/15/2023
• Device Catalogue Number: 2J8002
• Device Lot Number: DR18H13071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2018
• 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