INTRAVIA 2B8019Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00085412003504), received between Mar 23, 2018 and Sep 11, 2026 — classified as 3 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (20 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 45 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Loose or Intermittent Connection; Device Contamination with Chemical or Other Material

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740251 ↗
• InjurySep 11, 2026Loose or Intermittent Connection; Device Contamination with Chemical or Other Material

  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, MW6002232.THIS REPORT CAPTURES IV BAG 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740190 ↗
• InjurySep 11, 2026Loose or Intermittent Connection; Device Contamination with Chemical or Other Material

  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:MW6002231, MW6002232.THIS REPORT CAPTURES IV BAG 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739998 ↗
• MalfunctionSep 10, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721663 ↗
• MalfunctionSep 10, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721617 ↗
• MalfunctionSep 1, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50536356 ↗
• MalfunctionJul 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50068887 ↗
• MalfunctionMar 6, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER (PM) IN THE FLUID PATH OF AN UNSPECIFIED QUANTITY OF 50 ML INTRAVIA CONTAINERS. WHEN THE PORT IS PUNCTURED, A SMALL PIECE OF PLASTIC DISLODGES INTO THE BAG. THE FOREIGN MATERIAL APPEARS TO BE A FRAGMENT OF THE PORT INTRODUCED DURING NEEDLE INSERTION. THE PARTICULATE WAS OBSERVED WITHIN THE FLUID PATH AND WAS NOT EMBEDDED IN THE PRODUCT. IT WAS DETECTED AFTER ADDING MEDICATION OR DURING RECONSTITUTION. THE ABRAXANE BAG WAS SUBSEQUENTLY REMADE, AND THE AFFECTED BAG HAS BEEN QUARANTINED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531391 ↗
• MalfunctionOct 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) 50ML INTRAVIA CONTAINERS WERE LEAKING FROM WHERE THE CLEAR AND BLUE TUBING MEET ON THE RIGHT-HANDED TUBE OF THE BAG. THE FIRST LEAK WAS OBSERVED AFTER FILLING AND THE SECOND BAG WAS USED WHICH ALSO LEAKED. 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 23330011 ↗
• MalfunctionAug 14, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A 50ML INTRAVIA BAG WAS LEAKING. THE LEAK WAS OBSERVED ON THE SIDE OF THE DOSING PORT WHERE THE COLLAR MEETS THE BAG AS WELL AS THE SPACE THE NEEDLE TYPICALLY OCCUPIES UPON DOSING. 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 22804706 ↗
• MalfunctionJul 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INJECTION PORT OF FOUR (4) 50 ML CAPACITY INTRAVIA CONTAINERS HAD ISSUES. THE PORT HAD COME OFF THE BAG DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22546034 ↗
• MalfunctionMar 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 50ML INTRAVIA BAG LEAKED ON THE SIDE OF THE DOSING (INJECTION) PORT WHERE THE PORT TUBING FROM THE BAG MEETS THE PORT INSERT. THIS WAS OBSERVED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586871 ↗
• MalfunctionNov 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 50 ML INTRAVIA CONTAINER LEAKED DUE TO A COMPROMISED SEAL WHERE THE DOSING PORT AND BAG MEET. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598740 ↗
• MalfunctionOct 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 50 ML INTRAVIA CONTAINER LEAKED AND FLUID WAS COMING FROM SIDE PORT SEAL. THIS OCCURRED DURING SHIPPING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20413093 ↗
• MalfunctionOct 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 50 ML INTRAVIA CONTAINER LEAKED FROM THE SIDE OF THE INJECTION PORT. THIS WAS OBSERVED DURING INSPECTION/LABELLING/PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408669 ↗
• MalfunctionOct 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 50 ML INTRAVIA CONTAINER LEAKED WHERE THE PORT IS WELDED TO THE BAG. THIS WAS OBSERVED DURING SHIPPING ACTIVITIES. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407995 ↗
• MalfunctionSep 11, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN INTRAVIA 50 ML CAPACITY CONTAINER HAD FOREIGN PARTICULATE MATTER. FTIR (FOURIER TRANSFORM INFRARED SPECTROSCOPY) IDENTIFIED WADDING MATERIAL AND PAPER PARTICULATE INSIDE THE FINISHED PRODUCT THAT THIS DEVICE WAS USED WITH DURING THE COMPOUNDING PROCESS. THE PARTICULATES WERE OBSERVED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195862 ↗
• MalfunctionSep 11, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN INTRAVIA 50 ML CAPACITY CONTAINER HAD FOREIGN PARTICULATE MATTER. FTIR (FOURIER TRANSFORM INFRARED SPECTROSCOPY) IDENTIFIED WOOL PARTICULATE INSIDE THE FINISHED PRODUCT THAT THIS DEVICE WAS USED WITH DURING THE COMPOUNDING PROCESS. THE PARTICULATES WERE OBSERVED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20194603 ↗
• MalfunctionApr 18, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN PARTICULATE MATTER (PM) WAS OBSERVED IN TWO (2) 50 ML INTRAVIA CONTAINERS. THE PM WAS FURTHER DESCRIBED AS AN EXTRINSIC PARTICLE ¿POLYESTER FIBER AND WOOL¿ AND ¿DWG OIL¿. THIS WAS IDENTIFIED VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) 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 19139332 ↗
• MalfunctionApr 18, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN PARTICULATE MATTER (PM) WAS OBSERVED IN A 50 ML INTRAVIA CONTAINER. THE PM WAS FURTHER DESCRIBED AS AN EXTRINSIC PARTICLE ¿GABRIELLE¿. THIS WAS IDENTIFIED VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) 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 19139183 ↗
• MalfunctionApr 10, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN PARTICULATES WERE OBSERVED IN A 50 ML INTRAVIA CONTAINER. THE FOREIGN PARTICULATES WERE DESCRIBED AS EXTRINSIC PARTICLES THAT WERE DISCOVERED DURING FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) TESTING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19084492 ↗
• MalfunctionApr 10, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN PARTICULATES WERE OBSERVED IN A 50 ML INTRAVIA CONTAINER. THE FOREIGN PARTICULATES WERE DESCRIBED AS EXTRINSIC PARTICLES THAT WERE DISCOVERED DURING FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) TESTING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19084490 ↗
• MalfunctionDec 22, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A 50 ML INTRAVIA CONTAINER HAD PUNCTURE HOLES IN THE PORT. THIS WAS OBSERVED WHEN THE BAG WAS ATTACHED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384672 ↗
• MalfunctionNov 21, 2023Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PORTS OF AN UNSPECIFIED QUANTITY OF 50 ML CAPACITY INTRAVIA CONTAINERS WERE STARTING TO FRAY. IT WAS FURTHER STATED THAT THERE WAS AN INCIDENT WHERE THE PORT COMPLETELY CAME OFF AFTER BEING PUNCTURED. THIS WAS DISCOVERED DURING SET-UP/PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18183420 ↗
• MalfunctionJul 31, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 50ML INTRAVIA CONTAINER WAS LEAKING FROM THE TUBING. THE LEAK WAS DISCOVERED BY THE CUSTOMER UPON RECEIPT OF THE SHIPMENT DURING THEIR ORDER RECONCILIATION BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17425735 ↗

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