INTRAVIA 2B8014Recalls & reported problems
Baxter International Inc. · INTRAVIA Container, 1000 mL Capacity · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Baxter INTRAVIA IV container is a flexible bag used to hold compounded sterile preparations. Most of the 44 reports describe white filament-like particles or other contamination found inside the bag before it was given to a patient, along with some leaking at the bottom seam. There are no deaths and no injuries. No recalls name this device. Reports have risen sharply, from 3 in the prior 12 months to 21 in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00085412000046), received between Aug 21, 2018 and Sep 15, 2026 — classified as 43 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (28 reports).
3 other recalls cover devices cleared under the same FDA submission (K964853); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material28
- Fluid/Blood Leak10
- Component Missing2
- Contamination1
- Crack1
- Detachment of Device or Device Component1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- No Patient Involvement8
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Device Contamination with Chemical or Other Material
It was reported that eight (8) Empty INTRAVIA Containers had white, plastic-like particulate matter. The issue was noticed during inspection for del Nido. There was no patient involvement. No additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766739 ↗MalfunctionAug 28, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50499593 ↗MalfunctionJul 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50093450 ↗MalfunctionJun 19, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT "BAG FILAMENTS" WERE OBSERVED IN THREE (3) 1000 ML INTRAVIA CONTAINERS. THE PARTICULATE MATTER WAS IDENTIFIED DURING DOSING OF THE BAGS, AT WHICH TIME THE FILAMENTS WERE REPORTED TO DISLODGE INTO THE SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25565744 ↗MalfunctionMay 29, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PARTICULATE MATTER (PM) WAS FOUND INSIDE THIRTY SIX (36) 1000ML INTRAVIA CONTAINERS. THE PM WAS DESCRIBED AS WHITE FILAMENT FLOATING IN THE BAGS. NO PATIENT WAS CONNECTED AT THE TIME OF THIS EVENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25335328 ↗MalfunctionMay 26, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THIRTY FOUR (34) EMPTY INTRAVIA CONTAINERS HAD PARTICULATES INSIDE THE BAGS. THIS WAS NOTICED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25295096 ↗MalfunctionApr 23, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT NINETEEN (19) 1000ML INTRAVIA CONTAINERS HAD INTRINSIC PARTICULATES IN THE BAGS. THIS WAS OBSERVED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24973768 ↗MalfunctionApr 9, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT SIXTY-EIGHT (68) 1000ML INTRAVIA CONTAINERS HAD PARTICULATE MATTER INSIDE THE BAGS. THIS WAS OBSERVED DURING INSPECTION, AFTER FILLING. PARTICULATE MATTER WAS NOT OBSERVED WHEN THE BAGS WERE EMPTY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24829861 ↗MalfunctionApr 9, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT TEN (10) UNITS OF EMPTY INTRAVIA CONTAINERS HAD PLASTIC PARTICLES IN THE MEDICATION. THIS WAS OBSERVED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24827662 ↗MalfunctionApr 3, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT MULTIPLE UNITS OF EMPTY INTRAVIA CONTAINER 1000 MLS HAD PARTICULATE MATTERS INSIDE THE BAGS. THE DEVICES CONTAINED ROPIVACAINE. THIS WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24773176 ↗MalfunctionApr 2, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT MULTIPLE UNITS OF EMPTY INTRAVIA CONTAINER 1000 MLS HAD PARTICULATE MATTERS INSIDE THE BAGS. THE DEVICES CONTAINED ROPIVACAINE. THIS WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24770507 ↗MalfunctionApr 1, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT TWENTY-TWO (B)(6) UNITS OF EMPTY INTRAVIA CONTAINER 1000 MLS HAD PARTICULATE MATTERS INSIDE THE BAGS. THE DEVICES CONTAINED ROPIVACAINE. THIS WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754031 ↗MalfunctionApr 1, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT TWENTY NINE (29) UNITS OF EMPTY INTRAVIA CONTAINER 1000 MLS HAD PARTICULATE MATTERS INSIDE THE BAGS. THE DEVICES CONTAINED ROPIVACAINE. THIS WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754029 ↗MalfunctionFeb 18, 2026Component Missing
IT WAS REPORTED THAT FOUR (4) EMPTY INTRAVIA CONTAINERS 1000 ML HAD MISSING BLUE CAPS. THIS WAS OBSERVED AFTER THE BAGS WERE FILLED WITH CARDIOPLEGIA SOLUTION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24383940 ↗MalfunctionJan 23, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT TWO (2) EMPTY INTRAVIA CONTAINERS RIPPED AT THE SEAM WHERE THE PORTS ATTACH TO THE BAG. THE ISSUE WAS NOTICED DURING 'ILP' STAGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24171422 ↗MalfunctionJan 22, 2026Component Missing
IT WAS REPORTED THAT THE BLUE PORT COVER OF AN EMPTY INTRAVIA CONTAINER WAS MISSING. THE ISSUE WAS NOTICED DURING PROCESS STAGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24150283 ↗MalfunctionJan 8, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER (PM) OBSERVED WITHIN A 1000ML INTRAVIA CONTAINER. AFTER MIXING ORITAVANCIN, IT WAS OBSERVED THAT THERE WAS A FLOATER IN THE BAG WHICH APPEARED LIKE A STRING. THIS ISSUE WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24014487 ↗MalfunctionDec 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT FOUR (4) 1000 ML EMPTY INTRAVIA CONTAINERS HAD THE BLUE PORTS FALLING OFF. THIS WAS OBSERVED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23821434 ↗MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A 1000 ML EMPTY INTRAVIA CONTAINER LEAKED. THE ISSUE WAS IDENTIFIED DURING THE INSPECTION, LABELLING AND PACKAGING PROCESS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23817805 ↗MalfunctionDec 11, 2025Contamination
AFTER COMPETITION OF MIXING ORITAVANCIN TECHNICIAN NOTICED A FLOATER IN THE BAG ( LOOKS LIKE A A STRING) . ALERTED PHARMACIST . MEDICATION WAS REMADE. EMPTY BAG BAXTER ( NTRAVIA 1000 ML CONTAINER WAS USED. LOT DR23E10079, 2B8014.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778940 ↗MalfunctionJul 30, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER (PM) IN A 1000ML INTRAVIA CONTAINER WHILE COMPOUNDING. THE PM WAS DESCRIBED AS SMALL GLASS/PLASTIC PARTICLE FOUND INSIDE THE SOLUTION/FLUID PATH. THE PM WAS OBSERVED WHILE COMPOUNDING INTRAVENOUS OXYTOCIN. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22669417 ↗MalfunctionJun 6, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER (PM) IN A 1000ML INTRAVIA CONTAINER WHILE COMPOUNDING. THE PM WAS DESCRIBED AS SMALL, CLEAR, AND HARD, AND WAS CONTAINED WITHIN THE PRODUCT. THE PM WAS OBSERVED WHILE COMPOUNDING INTRAVENOUS OXYTOCIN. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22159177 ↗MalfunctionNov 22, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A 1000ML EMPTY INTRAVIA CONTAINER HAD A PIECE OF WHAT APPEARED TO BE PLASTIC (PART OF THE BAG). THE PLASTIC PIECE WAS LOCATED INSIDE THE SOLUTION/FLUID PATH. THIS WAS OBSERVED AFTER THE CONTAINER WAS FILLED WITH 380MG MESNA IN 1000ML OF DEXTROSE 5% IN 0.45% SODIUM CHLORIDE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20761613 ↗MalfunctionJun 2, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT SMALL PARTICULATES WERE OBSERVED IN TWO (2) 1000ML EMPTY INTRAVIA CONTAINER. THIS WAS OBSERVED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14580219 ↗MalfunctionJun 2, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT SMALL PARTICULATES WERE OBSERVED IN A 1000ML EMPTY INTRAVIA CONTAINER. THIS WAS OBSERVED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14580210 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K964853. One submission often covers many models, so check the product and lot details in each record.
- Z-0485-2018 · Jul 27, 2017 · TerminatedEmpty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
- Z-0085-2015 · Sep 16, 2014 · TerminatedBaxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is in
- Z-0084-2015 · Sep 16, 2014 · TerminatedBaxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use i
Other CONTAINER, I.V. devices
- INTRAVIA 2B8011Baxter International Inc. · CONTAINER, I.V.127 reports
- INTRAVIA 2B8012Baxter International Inc. · CONTAINER, I.V.119 reports
- APEX™ 2112531B. Braun Medical Inc. · CONTAINER, I.V.69 reports
- APEX™ 2112530B. Braun Medical Inc. · CONTAINER, I.V.66 reports
- INTRAVIA 2B8013Baxter International Inc. · CONTAINER, I.V.64 reports
- SECURE® 66040Metrix Company, The · Container, I.V.1 recall8 reports
- MICROTEK 1Microtek Medical LLC · CONTAINER, I.V.1 recall8 reports
- SECURE® 66045Metrix Company, The · Container, I.V.1 recall7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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