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

Catalog Number 2B8012

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 03/28/2023

Event Type  malfunction  

Event Description

It was reported that injection port of a 250ml intravia container was damaged and resulted in fluid leakage.This issue was further described as, ¿the septum of the injection port being to crumble/flake and fall out then began leaking through the resulting pathway¿.This event occurred while filling the bag with medication prior to patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction b5: the reporter stated the bags were stored out in the light in ziplock bags under room temperature conditions (omitted on the initial report).D9: updated device available for evaluation to yes with date.H3: device returned for evaluation was changed from no to yes.H6: type of investigation was updated from b17 to b01 for the actual sample received.Investigation findings were changed from c20 to c1802 and investigation conclusions were changed from d15 to d04.H10: three (3) actual samples were received for evaluation.A visual inspection was performed with the naked eye which noticed roughness and separation at the injection port; however, the other components were placed according to the specification.The reported condition of leak was not verified, however, the reported condition of ¿septum of the injection port being to crumble/flake and fall out¿ was verified.The cause of the condition was determined to be due to storage conditions; such as environmental conditions where the product is stored and constantly exposed to any light (especially uv-light), oxygen, ozone, heat, humidity.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: 16788639
• MDR Text Key: 314167131
• Report Number: 1416980-2023-01920
• Device Sequence Number: 1
• Product Code: KPE
• UDI-Device Identifier: 00085412003191
• UDI-Public: (01)00085412003191
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2B8012
• Device Lot Number: DR22A28109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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