INTRAVIA 2J8003Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00085412029566), received between Jan 2, 2018 and May 7, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (13 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Material Too Rigid or Stiff

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF 500 ML INTRAVIA CONTAINERS HAD INJECTION PORTS THAT BECAME BRITTLE. THIS WAS OBSERVED BEFORE USE. THE BAGS WERE STORED WITHOUT THE OVERWRAP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112188 ↗
• MalfunctionApr 24, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A 500ML INTRAVIA CONTAINER WAS LEAKING FROM AROUND THE PORTS. THE PATIENT HAD GONE HOME WITH MEDICATION (UNSPECIFIED CHEMOTHERAPY) FOR 24 HOURS. IT WAS NOTED UPON THEIR RETURN TO THE CHEMO SUITE TO DISCONNECT THE DRUG. THE LEAK WAS OBSERVED 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 24987830 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF 500ML INTRAVIA CONTAINERS HAD THE PORTS DETACH RESULTING IN DRUG LEAKAGE. THIS WAS OBSERVED DURING COMPOUNDING, AFTER THE PORT WAS PUNCTURED WITH A NEEDLE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561102 ↗
• MalfunctionFeb 18, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWO (2) NON-DEHP FLUID PATH INTRAVIA CONTAINERS HAD PARTICULATES DESCRIBED AS SMALL PLASTIC STRANDS THAT WERE NOT EMBEDDED BUT WERE FREELY MOVING IN THE SOLUTION. THE ISSUE WAS OBSERVED WHILE VISUALIZATION DURING POST-COMPOUNDING OF IV SOLUTIONS. THE DEVICES CONTAINED ADMIXTURE SOLUTIONS. THE FOLLOWING MEDICATION, ADDITIVE, OR RECONSTITUTION SOLUTIONS WERE INTRODUCED; THAM SOLUTION, ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION (CP2D), DEXTROSE 50% INJECTION, POTASSIUM CHLORIDE AND STERILE WATER FOR INJECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383480 ↗
• MalfunctionDec 30, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AT LEAST ONE NON-DEHP FLUID PATH INTRAVIA CONTAINER HAD DEBRIS INSIDE THE BAG AND UPON CLOSER INSPECTION IT APPEARED TO BE A ROUND PIECE OF PLASTIC FLOATING IN THE BAG. THE ISSUE WAS NOTICED WHILE PREPARING A DOSE OF MEDICATION. THE BAG CONTAINED THE DRUG BLINATUMUMAB. A NEW DOSE WAS PREPARED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927384 ↗
• MalfunctionDec 30, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AT LEAST ONE NON-DEHP FLUID PATH INTRAVIA CONTAINER HAD DEBRIS INSIDE THE BAG, UPON CLOSER INSPECTION IT APPEARED TO BE A ROUND PIECE OF PLASTIC FLOATING IN THE BAG. THE ISSUE WAS NOTICED WHILE PREPARING A DOSE OF MEDICATION. A NEW DOSE WAS PREPARED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927214 ↗
• MalfunctionDec 30, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AT LEAST ONE NON-DEHP FLUID PATH INTRAVIA CONTAINER HAD DEBRIS INSIDE THE BAG. UPON FURTHER INSPECTION, IT APPEARED TO BE A ROUND PIECE OF PLASTIC FLOATING IN THE BAG. THIS WAS DISCOVERED WHILE PREPARING A DOSE OF BLINATUMUMAB. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23925040 ↗
• MalfunctionDec 30, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AT LEAST ONE NON-DEHP FLUID PATH INTRAVIA CONTAINER HAD DEBRIS INSIDE THE BAG. UPON FURTHER INSPECTION, IT APPEARED TO BE A ROUND PIECE OF PLASTIC FLOATING IN THE BAG. THIS WAS DISCOVERED WHILE PREPARING A DOSE OF MEDICATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924704 ↗
• MalfunctionJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FILL PORT STOPPER OF A 500 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 22569736 ↗
• MalfunctionFeb 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE END OF THE MEDICATION PORT OF A 500 ML CAPACITY INTRAVIA CONTAINER WAS LOOSE AND ENDED COMING OFF THE BAG WHILE IT WAS IN THE HOOD. THIS WAS NOTICED WHILE MIXING CHEMO PRIOR TO PATIENT USE. IT WAS FURTHER INFORMED THAT " THE WHITE STRIPPING THAT GOES AROUND IT ON SOME BAGS DOES NOT GO ALL THE WAY TO THE END, SO IT DOES NOT SECURE IT IN PLACE". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21460948 ↗
• MalfunctionJan 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTRAVIA CONTAINER 500 ML CAPACITY LEAKED FROM THE SIDE OF THE BAG (BESIDE MEMBRANE PORT). THE BAG HAD PREVIOUSLY BEEN CONNECTED TO A CLOSED SYSTEM BAG SPIKE. WHEN AN UNSPECIFIED TEST SOLUTION WAS ADDED TO THE BAG, IT IMMEDIATELY LEAKED FROM THE SIDE. THIS OCCURRED DURING A MEDIA FILL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137975 ↗
• MalfunctionDec 5, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A CLEAR PIECE OF PLASTIC WAS FOUND INSIDE THE SOLUTION/FLUID PATH OF AN UNSPECIFIED QUANTITY OF 500ML NON-DEHP FLUID PATH INTRAVIA CONTAINERS. THIS WAS OBSERVED PRIOR TO SPIKING OR RECONSTITUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857037 ↗
• MalfunctionDec 5, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A CLEAR PIECE OF PLASTIC WAS FOUND INSIDE THE SOLUTION/FLUID PATH OF AN UNSPECIFIED QUANTITY OF 500ML NON-DEHP FLUID PATH INTRAVIA CONTAINERS. THIS WAS OBSERVED PRIOR TO SPIKING OR RECONSTITUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856091 ↗
• MalfunctionJan 29, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 500 ML NON-DEHP FLUID PATH INTRAVIA CONTAINER LEAKED; THE INNER CORE OF THE INJECTION PORT DISLODGED. THIS WAS OBSERVED WHEN THE NEEDLE WAS WITHDRAWN AFTER INJECTING FLUID. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602945 ↗
• MalfunctionNov 17, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PARTICLE WAS FOUND FLOATING IN A 500ML INTRAVIA CONTAINER. THIS WAS OBSERVED BEFORE PATIENT USE. THE BAG WAS FILLED WITH HYDROMORPHONE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165324 ↗
• MalfunctionOct 19, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 500 ML CAPACITY NON-DEHP FLUID PATH INTRAVIA CONTAINER LEAKED AT THE ADMINISTRATION PORT WHEN IT WAS SPIKED BY THE NURSE. THIS WAS DISCOVERED DURING SET-UP AND PREPARATION. UPON FURTHER INSPECTION, A PART OF THE ADMINISTRATION PORT WAS MISSING (DETACHED). THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965716 ↗
• MalfunctionJul 24, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT A NON-DEHP FLUID PATH INTRAVIA CONTAINER 500 ML CAPACITY HAD A CONNECTION ISSUE. THE SECONDARY SET WAS NOT SECURED AND EASILY REMOVED FROM THE PORT. THE SECONDARY SET WAS FALLING OUT OF THE FLUID BAG. THE ISSUE OCCURRED AFTER THE PHARMACIST DISPENSED MEDICATION TO BE DRAINED INTO THE EMPTY CONTAINER. 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 17381297 ↗
• MalfunctionMay 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK WAS FOUND FROM AN UNSPECIFIED LOCATION DURING USE OF A 500ML INTRAVIA CONTAINER. THIS WAS DISCOVERED DURING STORAGE, PRIOR TO PATIENT USE. THE BAG CONTAINED BLINATUMOMAB AND WAS ATTACHED TO A PRIMED NON-BAXTER ADMINISTRATION SET WITH AN IN-LINE FILTER; THE PRODUCT WAS PLACED IN A ZIPLOCK BAG AND STORED IN A HARD SIDED BIN IN THE FRIDGE. THE PHARMACIST INSPECTED THE DOSE AND THERE WAS NO EVIDENCE OF LEAKAGE FOUND. THE NURSE FOUND FLUID INSIDE THE ZIPLOCK BAG THE FOLLOWING DAY. A NEW DOSE WAS PREPARED USING A NEW BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916226 ↗
• MalfunctionOct 19, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FOUR (4) NON-DEHP FLUID PATH INTRAVIA CONTAINERS 500 ML CAPACITY LEAKED AT THE MIDDLE PORT SEAM DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632032 ↗
• 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 NON-DEHP FLUID PATH 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 14579673 ↗
• 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 NON-DEHP FLUID PATH 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 14579624 ↗
• MalfunctionMar 29, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FLOATING PARTICULATES WERE FOUND IN FIFTEEN (15) NON-DEHP FLUID PATH INTRAVIA CONTAINERS CONTAINING COMPOUNDED PRODUCT. THIS WAS IDENTIFIED DURING FINAL PRODUCT INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585599 ↗
• MalfunctionFeb 13, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICULATE MATTER WAS DISCOVERED FLOATING IN THE SOLUTION WITHIN FIVE (5) 500ML INTRAVIA CONTAINERS. THIS WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9706558 ↗
• MalfunctionJan 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT AT LEAST FOUR (4) INTRAVIA CONTAINERS 500 ML WERE LEAKING. TWO (2) CONTAINERS WERE LEAKING FROM THE PORT, ONE (1) CONTAINER WAS LEAKING FROM THE BOTTOM SEAM, AND AN UNSPECIFIED QUANTITY OF CONTAINERS WERE LEAKING FROM UNSPECIFIED LOCATIONS. OF THE FOUR EVENTS, THREE OCCURRED PRIOR TO PATIENT USE AND IN ONE EVENT IT WAS NOT SPECIFIED IF THERE WAS PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8287309 ↗
• MalfunctionSep 7, 2018Break; Break

  IT WAS REPORTED THAT THE INJECTION PORT OF TWENTY-TWO (22) INTRAVIA CONTAINERS WERE BROKEN. THE ISSUE WAS FURTHER DESCRIBED AS RUBBER COMING OUT WHEN THE NEEDLE IS WITHDRAWN FROM THE BAG FOLLOWING FILLING OF THE CONTAINER WITH MEDICATION. THIS EVENT WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7856348 ↗

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-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
• 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