INTRAVIA 2J8002Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00085412029573), received between Apr 25, 2018 and Jan 23, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (10 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER (PM) WITHIN THE FLUID PATH A 250ML INTRAVIA CONTAINER. WHEN REMOVING THE SPIKE OF AN UNSPECIFIED SET FROM A FINISHED VANCOMYCIN DOSE, IT WAS OBSERVED THAT THERE WAS PLASTIC STUCK AROUND THE SPIKE WHICH INDICATED PM FROM THE INTRAVIA BAG. 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 24164634 ↗
• MalfunctionJan 16, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A 250ML INTRAVIA CONTAINER HAD PARTICULATE MATTER (PM) INSIDE THE SOLUTION/FLUID PATH. THIS ISSUE WAS OBSERVED AFTER ADDING ANOTHER MEDICATION (BLINATUMOMAB) OR AFTER RECONSTITUTION (VIALS). 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 24104190 ↗
• MalfunctionJan 16, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOUR (4) 250ML INTRAVIA CONTAINERS HAD PARTICULATE MATTER (PM) INSIDE THE SOLUTION/FLUID PATH. THIS ISSUE WAS OBSERVED AFTER ADDING ANOTHER MEDICATION (BLINATUMOMAB) OR AFTER RECONSTITUTION (VIALS). 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 24104143 ↗
• MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP FLUID PATH INTRAVIA CONTAINER 250 ML CAPACITY LEAKED FROM THE SEAL NEAR THE INTRAVENOUS PORTS. THE DEVICE CONTAINED FOUR (4) VIALS OF FIBRINOGEN. THIS WAS DISCOVERED PRIOR TO SHIPPING THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728239 ↗
• MalfunctionJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FILL PORT STOPPER OF A 250 ML CAPACITY INTRAVIA CONTAINER CAME OUT WHEN THE NEEDLE WAS REMOVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569701 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED A NON-DEHP FLUID PATH 250 ML INTRAVIA CONTAINER HAD BROKE AT THE CONNECTION TO THE TUBING AND A SMALL PLASTIC PIECE FROM THE BAG WAS STUCK INTO THE INTRAVENOUS TUBING. THIS ISSUE OCCURRED WHILE CONNECTING NORMAL SALINE FLUSH TO THE TUBING TO FLUSH CHEMOTHERAPY MEDICATION THROUGH THE LINE. 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 22021768 ↗
• MalfunctionFeb 24, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MEDICATION PORT CAME OUT IN AT LEAST ONE 250 ML INTRAVIA CONTAINER. AFTER FILLING THE CONTAINER WITH AN UNSPECIFIED MEDICATION, THE INTERNAL SECTION OF THE MEDICATION PORT CAME OUT WHILE WITHDRAWING THE UNSPECIFIED NEEDLE. IT WAS ALSO NOTED THAT THE PORTS IN FIVE (5) OTHER BAGS WERE FOUND TO BE 'DRIED OUT/DRY ROT'. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21450359 ↗
• MalfunctionSep 27, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO (2) 250ML NON-DEHP FLUID PATH INTRAVIA CONTAINERS HAD DAMAGED PORTS RESULTING IN MEDICATION TO LEAK OUT. THIS OCCURRED WHILE REMOVING THE SYRINGE AND NEEDLE AFTER INJECTING THE MEDICATION INTO THE INJECTION PORT ON A BAG. THE ENTIRE CIRCULAR INJECTION PORT CAME OUT OF THE INTRAVIA BAG, LEAVING AN OPEN PORT. A SECOND INTRAVIA BAG WAS USED TO MIX ANOTHER BAG OF MEDICATION, AND THE INJECTION PORT WAS ABLE TO BE REMOVED WITH THE FINGERS ONLY. A THIRD BAG WAS USED TO MIX THE MEDICATION PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20327143 ↗
• MalfunctionAug 12, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF INTRAVIA 250 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 19968565 ↗
• MalfunctionDec 26, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PARTICLE DISLODGED FROM THE PORT SITE OF A 250 ML NON-DEHP FLUID PATH INTRAVIA CONTAINER. A SMALL, ROUND, CLEAR PLASTIC PARTICLE WAS FLOATING IN THE SOLUTION. THIS WAS OBSERVED DURING COMPOUNDING; THE BAG CONTAINED BLINATUMOMAB. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18395533 ↗
• MalfunctionSep 20, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A NON-DEHP FLUID PATH INTRAVIA CONTAINER 250 ML CAPACITY LEAKED FROM THE INJECTION SITE. DURING COMPOUNDING, WHEN THE NEEDLE WAS PULLED OUT OF THE INJECTION SITE, THE ENTIRE INJECTION SITE FELL OFF AND THE DRUGS LEAKED FROM THE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17784070 ↗
• MalfunctionJul 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE STOPPER OF A 250ML NON-DEHP FLUID PATH INTRAVIA CONTAINER COMPLETELY CAME OUT FROM THE INJECTION PORT WITH THE NEEDLE. THE ISSUE WAS IDENTIFIED DURING COMPOUNDING, WHEN AFTER THE FIRST NEEDLE STICK. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17353132 ↗
• MalfunctionJul 18, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TOP OF THE BLUE PORT OF TEN (10) EMPTY INTRAVIA CONTAINERS WERE CRACKED WHICH RESULTED IN A LEAK. THE LEAKS WERE DISCOVERED IN THE PHARMACY ROOM AND NEONATAL INTENSIVE CARE UNIT (NICU) PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342937 ↗
• MalfunctionMay 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTRAVIA CONTAINER LEAKED AT THE NOT-SPIKED PORT. THIS WAS IDENTIFIED DURING SET-UP/PREPARATION, PRIOR TO PATIENT ADMINISTRATION OF NIVOLUMAB. THE PHARMACY MIXED A NEW BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16912260 ↗
• MalfunctionJun 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN UNSPECIFIED QUANTITY OF NON-DEHP FLUID PATH INTRAVIA CONTAINERS LEAKED (NOT FURTHER SPECIFIED). THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14602028 ↗
• MalfunctionMay 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP FLUID PATH INTRAVIA CONTAINERS 250 ML CAPACITY LEAKED FROM AN UNSPECIFIED LOCATION. THE ISSUE WAS IDENTIFIED DURING AN UNSPECIFIED PROCESS STEP. 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 14518061 ↗
• MalfunctionMay 18, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A NON-DEHP FLUID PATH INTRAVIA CONTAINER 250 ML CAPACITY HAD CLEAR PLASTIC FOUND IN THE BAG THAT IS NOT VISUALLY SIMILAR TO A CORE. THIS ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427952 ↗
• MalfunctionMay 10, 2022Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE UNSPECIFIED QUANTITY OF INTRAVIA CONTAINERS 250 ML CAPACITY EXPERIENCED DISCONNECTIONS AND LEAKS FROM THE PORT. 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 14348965 ↗
• MalfunctionMar 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SEPTUM CAME OUT FROM THE INJECTION PORT OF A NON-DEHP FLUID PATH INTRAVIA CONTAINER 250 ML CAPACITY. THE ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13967171 ↗
• MalfunctionAug 3, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT (4) 250ML NON-DEHP FLUID PATH INTRAVIA CONTAINERS HAD PRECIPITATE INSIDE THE BAGS. THIS WAS IDENTIFIED AFTER FILLING WITH SODIUM CHLORIDE OR DEXTROSE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12269165 ↗
• MalfunctionMay 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT (2) 250ML NON-DEHP FLUID PATH INTRAVIA CONTAINERS HAD THE RUBBER PART WHERE THE BAG WAS SPIKED COME OFF AND REMAIN ON THE BLUNT CANNULA NEEDLE. THIS WAS OBSERVE WHEN THE NURSE WAS TRANSFERRING RECONSTITUTED SOLUTION TO THE BAG. THERE WAS NO A PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803372 ↗
• MalfunctionApr 30, 2021Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT THE ¿RUBBER PORTION¿ ON THE INJECTION PORT OF SIX (6) NON-DEHP FLUID PATH INTRAVIA CONTAINERS, 250 ML CAPACITY APPEARED ¿DRIED OUT¿ AND ABOUT TO CRUMBLE. THIS WAS FURTHER DESCRIBED BY THE CUSTOMER AS ¿THE CENTER APPEARED YELLOW BUT SURROUNDING WAS WHITE AND APPEARED LIKE IT WAS GOING TO CRUMBLE¿. IT WAS FURTHER OBSERVED THAT ALL OF THE OUTSIDE DEVICE WRAPPERS HAVE THREE (3) SMALL HOLES ACROSS THE TOP ¿ABOUT THE PERFORATED LINE TO OPEN THE PACKAGE¿. THIS WAS OBSERVED PRIOR TO PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11755204 ↗
• MalfunctionApr 30, 2021Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT THE "RUBBER PORTION" ON THE INJECTION PORT OF EIGHTEEN (18) NON-DEHP FLUID PATH INTRAVIA CONTAINERS, 250 ML CAPACITY APPEARED ¿DRIED OUT¿ AND ABOUT TO CRUMBLE. THIS WAS FURTHER DESCRIBED BY THE CUSTOMER AS ¿THE CENTER APPEARED YELLOW BUT SURROUNDING WAS WHITE AND APPEARED LIKE IT WAS GOING TO CRUMBLE¿. IT WAS FURTHER OBSERVED THAT ALL OF THE OUTSIDE DEVICE WRAPPERS HAVE THREE (3) SMALL HOLES ACROSS THE TOP ¿ABOUT THE PERFORATED LINE TO OPEN THE PACKAGE¿. THIS WAS OBSERVED PRIOR TO PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11755197 ↗
• MalfunctionApr 30, 2021Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT THE ¿RUBBER PORTION¿ ON THE INJECTION PORT OF EIGHTEEN (18) NON-DEHP FLUID PATH INTRAVIA CONTAINERS, 250 ML CAPACITY APPEARED ¿DRIED OUT¿ AND ABOUT TO CRUMBLE. THIS WAS FURTHER DESCRIBED BY THE CUSTOMER AS ¿THE CENTER APPEARED YELLOW BUT SURROUNDING WAS WHITE AND APPEARED LIKE IT WAS GOING TO CRUMBLE¿. IT WAS FURTHER OBSERVED THAT ALL OF THE OUTSIDE DEVICE WRAPPERS HAVE THREE (3) SMALL HOLES ACROSS THE TOP ¿ABOUT THE PERFORATED LINE TO OPEN THE PACKAGE¿. THIS WAS OBSERVED PRIOR TO PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11755192 ↗
• MalfunctionSep 28, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOUR (4) UNITS OF NON-DEHP FLUID PATH INTRAVIA CONTAINERS ¿HAD FLECKS OF PLASTIC IN THEM¿. THE CONTAINERS WERE FILLED WITH VANCOMYCIN. THIS WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10597149 ↗

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