INTRAVIA 2B8013Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00085412035260), received between Jan 5, 2018 and Sep 15, 2026 — classified as 64 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (29 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 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 an INTRAVIA Container contained particulate matter inside the solution/fluid path. The particulate matter was described as 'very fine, almost hair-like' material floating within the solution. The issue was observed during setup after Sterile Water for Injection, dextrose 50% vial, sodium chloride 4 mEq/mL intravenous solution, and heparin (PF) 100 unit/mL were added for a neonatal custom intravenous infusion. The bag was quarantined and a new bag was compounded to resolve the issue. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766671 ↗
• MalfunctionApr 29, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF INTRAVIA CONTAINERS LEAKED. THE DEVICES WERE IDENTIFIED TO BE LEAKING "BENEATH THE LOCATION OF THE SEAM OF THE BAG HANGER". THE ISSUES WERE 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 25033523 ↗
• MalfunctionApr 29, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF INTRAVIA CONTAINERS LEAKED. THE DEVICES WERE IDENTIFIED TO BE LEAKING "BENEATH THE LOCATION OF THE SEAM OF THE BAG HANGER". THE ISSUES WERE 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 25033437 ↗
• MalfunctionApr 28, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THREE (03) UNITS OF INTRAVIA CONTAINER, EMPTY 500 ML CAPACITY HAD PARTICULATE MATTERS INSIDE THE BAGS. THE DEVICES CONTAINED ROPIVACAINE. THIS WAS DISCOVERED AFTER FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25014896 ↗
• MalfunctionAug 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 500 ML INTRAVIA CONTAINER LEAKED. THE ISSUE WAS FURTHER DESCRIBED AS, THE DEVICE LEAKED AT THE SEAM WHERE THE BAG HANGS WHEN ADMINISTERING TO PATIENTS, OPPOSITE TO THE NON-BAXTER LABEL. THIS OCCURRED POST SHIPMENT TO THE HOSPITAL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22844505 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Material Perforation; Material Split, Cut or Torn; Fluid/Blood Leak; Material Perforation; Material Split, Cut or Torn

  IT WAS REPORTED THAT TWO (2) 500 ML CAPACITY INTRAVIA CONTAINERS LEAKED NEAR THE OPENING WHERE THE BAGS CAN BE HUNG. THIS OCCURRED DURING COMPOUNDING WHERE THE BAGS OPENED NEAR THE TOP. 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 22206106 ↗
• MalfunctionMay 14, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN EMPTY 500 ML CAPACITY INTRAVIA CONTAINER HAD PARTICULATE IN THE SOLUTION. THE PARTICULATE WAS A LARGE SOLID WHITE PLASTIC LOOKING PARTICULATE. THE PARTICULATE BEST MATCHED THE INTERIOR SURFACE OF THE BAG SEPTUM. THIS 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 22023299 ↗
• MalfunctionOct 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWELVE (12) 500 ML EMPTY INTRAVIA CONTAINERS LEAKED DURING SHIPPING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20410205 ↗
• MalfunctionOct 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 500ML INTRAVIA CONTAINER LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED BEFORE USE IN TREATMENT. THERE WAS NO DAMAGE TO THE OUTER SHIPPING CONTAINER. THE BAG CONTAINED ROPIVACAINE 0.2% IN 500 ML NORMAL SALINE. 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 20407489 ↗
• MalfunctionSep 13, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED "FLOATERS" WERE OBSERVED IN AN INTRAVIA CONTAINERS. THE CONTAINER WAS "INJECTED" WITH 0.9% SODIUM CHLORIDE THEN RECONSTITUTED WITH 15GM AMPICILLIN/SULBACTUM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212585 ↗
• MalfunctionSep 9, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER (PM) WITHIN TWO (2) INTRAVIA CONTAINERS, EMPTY 500 ML CAPACITY. THE PM WAS DESCRIBED AS "FLOATERS" FOUND DURING THE INSPECTION PROCESS. THE DEVICES CONTAINED AMPICILLIN/SULBACTUM 15GM CONSTITUTED IN 0.9% SODIUM CHLORIDE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20176715 ↗
• MalfunctionAug 13, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF INTRAVIA 500 ML CAPACITY CONTAINERS HAD LARGE AIR BUBBLES APPEAR IN THE BAGS. THE BAGS ARE AIRED OUT COMPLETELY TO PREVENT ¿AIR-IN-LINE¿ PUMP ALARMS WHEN USED BY THE PATIENT; HOWEVER, WHEN CHECKING THE BAGS, SMALL AIR BUBBLES START TO APPEAR FROM THE DRUG ADDITIVE PORT AND COALESCE INTO BIG AIR BUBBLES. PATIENTS WOULD HAVE TO RE-PRIME THE LINE TO REMOVE THE AIR BUBBLES. 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 19976993 ↗
• MalfunctionAug 13, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF INTRAVIA 500 ML CAPACITY CONTAINERS HAD LARGE AIR BUBBLES APPEAR IN THE BAGS. THE BAGS ARE AIRED OUT COMPLETELY TO PREVENT ¿AIR-IN-LINE¿ PUMP ALARMS WHEN USED BY THE PATIENT; HOWEVER, WHEN CHECKING THE BAGS, SMALL AIR BUBBLES START TO APPEAR FROM THE DRUG ADDITIVE PORT AND COALESCE INTO BIG AIR BUBBLES. PATIENTS WOULD HAVE TO RE-PRIME THE LINE TO REMOVE THE AIR BUBBLES. 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 19976946 ↗
• MalfunctionAug 13, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF INTRAVIA CONTAINERS HAD LARGE AIR BUBBLES APPEAR IN THE BAG. THE BAG WAS AIRED OUT COMPLETELY TO PREVENT ¿AIR-IN-LINE¿ PUMP ALARMS WHEN USED BY THE PATIENT; HOWEVER, WHILE CHECKING THE BAGS, SMALL AIR BUBBLES STARTED TO APPEAR FROM THE DRUG ADDITIVE PORT AND COALESCED INTO BIG AIR BUBBLES. THE USER HAD TO RE-PRIME THE LINE TO REMOVE THE AIR BUBBLES. 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 19974486 ↗
• MalfunctionOct 18, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A 500ML INTRAVIA CONTAINER HAD A SMALL, THIN PIECE OF FOREIGN OBJECT INSIDE THE FLUID PATH. THIS WAS IDENTIFIED AFTER SPIKING THE BAG IN THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958906 ↗
• MalfunctionMay 12, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A 500ML INTRAVIA CONTAINER WAS LEAKING OUT FROM A CRACK SOMEWHERE ALONG THE TUBING. THIS WAS NOTICED DURING TRANSPORT FROM THE PHARMACY TO THE FLOOR. THE CONTAINER WAS FILLED WITH UNSPECIFIED MEDICATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924731 ↗
• MalfunctionApr 12, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE INNER TUBING OF THE ADMINISTRATION PORT SEPARATED FROM AN INTRAVIA CONTAINER WHICH RESULTED IN A FLUID LEAK. THIS ISSUE OCCURRED WHEN THE BLUE TIP PROTECTOR WAS PULLED FROM THE ADMINISTRATION PORT. THIS ISSUE WAS FURTHER DESCRIBED AS, 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, THEY REALIZED THE INNER TUBING CAME OUT WHEN IT WAS NOT SUPPOSED TO. THIS ISSUE OCCURRED DURING SETUP/PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16727262 ↗
• MalfunctionMar 15, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PORT FROM TWO (2) 500 ML INTRAVIA CONTAINERS COMPLETELY DISLODGED FROM THE BAG RESULTING IN A LEAK OF THE MEDICATION. THE ISSUE WAS IDENTIFIED WHEN PULLING THE BLUE STOPPER (TIP PROTECTOR) FROM THE BAGS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16546146 ↗
• MalfunctionFeb 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TUBING AND TIP PROTECTOR OF SIX (6) EMPTY 500ML INTRAVIA CONTAINER SEPARATED. THE TUBING CAME OUT WITH THE TIP PROTECTOR WHEN THE TIP PROTECTOR WAS REMOVED BY A NURSE. THE CONTAINERS WERE FILLED WITH UNSPECIFIED MEDICATION, AND THE PROBLEM WAS DETECTED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421600 ↗
• MalfunctionDec 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 500ML INTRAVIA CONTAINER WAS LEAKING FROM THE SEAL AROUND BOTH SIDES OF THE PORT. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS OCCURRED. 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 15928795 ↗
• MalfunctionJun 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTRAVIA CONTAINER LEAKED OUT OF THE BOTTOM OF THE BAG WITHOUT ANY ACCIDENTAL PUNCTURE OF THE BAG. THIS ISSUE WAS IDENTIFIED AFTER PRODUCT WAS PUT INTO THE BAG BEFORE USE ON A PATIENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14847339 ↗
• MalfunctionJun 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 500 ML INTRAVIA CONTAINER LEAKED. THIS WAS OBSERVED AFTER FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14841871 ↗
• 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 THREE (3) 500ML 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 14580271 ↗
• 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 500ML CAPACITY 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 14580021 ↗
• 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 500ML CAPACITY 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 14579661 ↗

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 · Terminated
  Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
• Z-0084-2015 · Sep 16, 2014 · Terminated
  Baxter 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
• Z-0085-2015 · Sep 16, 2014 · Terminated
  Baxter 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