MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER INTRAVIA 500ML CAPACITY EMPTY IV BAG; CONTAINER, I.V.

Model Number 2B8013

Device Problems Break (1069); Leak/Splash (1354); Detachment of Device or Device Component (2907)

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

Event Date 03/07/2023

Event Type  malfunction  

Event Description

Rituximab made for patient and placed into baxter intravia container 500ml capacity iv bag, lot dr22h18093.When rn pulled the blue tab off the port to administer, the inner tubing also came out which left the port as an open hole.Rn tried to spike it without the inner tubing and the medication leaked around the spike which made the rn question what happened to the port (at this point this is when they realized the inner tubing came out when it wasn't supposed to).High cost medication waste due to bag malfunction.New bag was made for patient and administered without any issues (same lot empty bag used).

• Brand Name: BAXTER INTRAVIA 500ML CAPACITY EMPTY IV BAG
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 16529266
• MDR Text Key: 311173197
• Report Number: MW5115661
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2B8013
• Device Catalogue Number: 2B8013
• Device Lot Number: DR22H18093
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1