MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTRAVIA CONTAINER 150 ML; CONTAINER IV

Lot Number DR20I17050

Device Problem Break (1069)

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

Event Date 01/26/2021

Event Type  malfunction  

Event Description

Baxter intravia 250 ml empty containers have a small plastic piece of the tubing port that breaks off when used with equashield ports upon compounding.It is the inner ring of plastic that can tear off when the adapter is pushed into the port.This plastic remains in the bag and is clearly visible.If you remove the blue shield on the port initially, you'll see a small hole cover of plastic that as you insert the equashield adapter, this plastic breaks off, instead remaining attached.This is only confirmed when fluid is added to the bag and you can identify visually a piece of plastic.Able to replicate on 2 different lot numbers (dr20h15023 and dr 20i17050).Were able to replicated this 3 times with 2 different technicians.

• Brand Name: INTRAVIA CONTAINER 150 ML
• Type of Device: CONTAINER IV
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 11243763
• MDR Text Key: 230128802
• Report Number: MW5099070
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/26/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: DR20I17050
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1