MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION Intravia Container 50 mL capacity; Container, I.V.

Lot Number	dr25l16048
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Describe event, problem, or product use error: multiple intravenous bags, once spiked, had large membranes come loose from the port and floating in the intravenous medication.3 occurred in the same day and i had been informed that other bags had the same flaw from previous days.Annex a: 1371,2944 annex e: 4582 annex f: 4652 annex g: 4755.Reference reports:mw6002230, mw6002231.This report captures iv bag 3.

• Brand Name: Intravia Container 50 mL capacity
• Common Device Name: Container, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 50740251
• Report Number: MW6002232
• Device Sequence Number: 9550863
• Product Code: KPE
• UDI-Device Identifier: 00085412003504
• UDI-Public: 00085412003504
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: dr25l16048
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown