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

Catalog Number 2B8019

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an intravia container was defective.The defect was further described as a leak coming from a crack on the injection port.This issue was identified prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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 evidence of a leaking bag; a crack was observed on the injection port.The components were in place per specifications.Due to the nature of the sample, no additional tests were performed.The reported condition was verified.The cause of the crack 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.

Manufacturer Narrative

Correction: b4/f8: date of this report in the initial mdr is being corrected from blank to 06/01/2021.

• Brand Name: INTRAVIA CONTAINER EMPTY
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11914618
• MDR Text Key: 253562799
• Report Number: 1416980-2021-03254
• Device Sequence Number: 1
• Product Code: KPE
• UDI-Device Identifier: 00085412003504
• UDI-Public: (01)00085412003504
• Combination Product (y/n): Y
• PMA/PMN Number: K964853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2B8019
• Device Lot Number: DR20I22050
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1