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

Catalog Number 2B8019

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the ports of an unspecified quantity of 50 ml capacity intravia containers were starting to fray.It was further stated that there was an incident where the port completely came off after being punctured.This was discovered during set-up/preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information was added to h3, h6, and h10.H10: the actual devices were not available; however, a photograph of the sample was provided for evaluation.The photograph was reviewed and roughness and separation of the injection site was observed.The reported condition was verified.The most probable cause identified could be related to the environmental conditions where the product is stored and constant exposure to any light - especially uv-light, oxygen, ozone, heat, humidity, or any stress.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
• Type of Device: 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: 18183420
• MDR Text Key: 328688430
• Report Number: 1416980-2023-06082
• Device Sequence Number: 1
• Product Code: KPE
• UDI-Device Identifier: 00085412003504
• UDI-Public: (01)00085412003504
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2B8019
• Device Lot Number: DR21A21017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.