APEX™ 2112530Recalls & reported problems
B. Braun Medical Inc. · EVA Single-Chamber Final Containers 1000 mL · Class 2
Quick summary
This B. Braun APEX EVA single-chamber IV container is a flexible bag used to hold intravenous fluids. Most of the 66 adverse event reports describe contamination found during inspection or production — particles, a hair, or other foreign matter inside sealed bags — along with a few labeling problems where the stated volume on the box did not match the overwrap and the actual contents. There are no deaths and no injuries reported, and no recalls name this device.
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
- 66
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 04046964539183), received between Mar 1, 2018 and May 18, 2026 — classified as 66 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (64 reports).
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
- Contamination /Decontamination Problem64
- Device Contamination with Chemical or Other Material1
- Labelling, Instructions for Use or Training Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- No Patient Involvement11
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DURING RAW MATERIAL INSPECTION, 1 PARTICULATE MATTER - EMBEDDED WAS LOCATED, CAUSING A FAILURE OF RAW MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25200361 ↗MalfunctionMay 11, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: SOME OF THESE UNITS WERE USED IN PRODUCTION AND FOUND TO HAVE 1 PARTICULATE MATTER - SOLUTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25141637 ↗MalfunctionApr 10, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: A HAIR WAS FOUND INSIDE A SEALED APEX CONTAINER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844062 ↗MalfunctionApr 6, 2026Labelling, Instructions for Use or Training Problem
AS REPORTED BY THE USER FACILITY: THE OUTER BOX IS LABELED 500 ML BUT INSIDE THE OVERWRAP IS LABELED 1000ML AND ACTUALLY IS 500 ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793126 ↗MalfunctionApr 3, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: LARGE PARTICULATES WERE IDENTIFIED IN THE SAMPLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24778138 ↗MalfunctionApr 3, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: LARGE PARTICULATES WERE IDENTIFIED IN THE SAMPLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24778137 ↗MalfunctionApr 3, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: LARGE PARTICULATES WERE IDENTIFIED IN THE SAMPLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24778134 ↗MalfunctionApr 2, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: LARGE PARTICULATES WERE IDENTIFIED IN THE SAMPLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765701 ↗MalfunctionApr 2, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: LARGE PARTICULATES WERE IDENTIFIED IN THE SAMPLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765698 ↗MalfunctionApr 2, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: LARGE PARTICULATES WERE IDENTIFIED IN THE SAMPLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765697 ↗MalfunctionApr 2, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: LARGE PARTICULATES WERE IDENTIFIED IN THE SAMPLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765696 ↗MalfunctionApr 2, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: LARGE PARTICULATES WERE IDENTIFIED IN THE SAMPLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765695 ↗MalfunctionApr 2, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: LARGE PARTICULATES WERE IDENTIFIED IN THE SAMPLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765692 ↗MalfunctionApr 2, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: LARGE PARTICULATES WERE IDENTIFIED IN THE SAMPLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765691 ↗MalfunctionApr 2, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: LARGE PARTICULATES WERE IDENTIFIED IN THE SAMPLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765690 ↗MalfunctionApr 2, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: LARGE PARTICULATES WERE IDENTIFIED IN THE SAMPLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765689 ↗MalfunctionMar 24, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: FOREIGN MATTER FLUID PATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24676143 ↗MalfunctionMar 17, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: FOREIGN MATTER FLUID PATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24619892 ↗MalfunctionMar 6, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, AN INSPECTION OF THE APEX SINGLE CHAMBER BAGS IDENTIFIED PARTICULATE MATTER. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24530334 ↗MalfunctionFeb 13, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: FOREIGN MATTER FLUID PATH IT IS TO BE NOTED THAT A 100% INSPECTION WAS APPROVED BY QA AS THERE WAS A HIGH NUMBER OF REJECTIONS FOR THIS LOT IN FINISHED PRODUCT, CAUSING LOW BATCH YIELDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24333552 ↗MalfunctionJan 12, 2026Contamination /Decontamination Problem
FOREIGN MATTER FLUID PATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24040422 ↗MalfunctionNov 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: WE HAVE INITIATED SCAR-01742 FOR APEX 1000 ML SINGLE CHAMBER BAGS. DURING RAW MATERIAL INSPECTION, ONE PARTICLE IN SOLUTION (WHITE FLAKE SPEC MOVING FREELY INSIDE BAG) AND ONE PARTICLE EMBEDDED (BLACK SPECK) WAS LOCATED, CAUSING A FAILURE OF RAW MATERIAL. NC-12144 HAS BEEN INITIATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23535580 ↗MalfunctionNov 11, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: WE HAVE INITIATED SCAR-01742 FOR APEX 1000 ML SINGLE CHAMBER BAGS. DURING RAW MATERIAL INSPECTION, THREE PARTICULATE MATTER EMBEDDED DEFECTS WERE LOCATED, CAUSING A FAILURE OF RAW MATERIAL. NC-12354 HAS BEEN INITIATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526683 ↗MalfunctionOct 24, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: NEPHRON HAS IDENTIFIED (X25) IV BAGS WITH BROWN RESIDUE ON THE INJECTION PORT FROM LOT# 25A24. AT THIS TIME (X155) BAGS RECEIVED WITH THE AFFECTED PRODUCT HAVE BEEN REJECTED FROM USE AND ARE AWAITING PRODUCT DISPOSITION BACK TO THE SUPPLIER IF REQUESTED OR WASTED. WE'D LIKE TO REQUEST REPLACEMENT PRODUCT BE PROVIDED IMMEDIATELY PLEASE. A PICTURE IS ATTACHED BELOW. IV BAGS WERE REJECTED DURING VISUAL INSPECTION DUE TO BROWN RESIDUE ON THE INJECTION PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23378529 ↗MalfunctionAug 26, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: WE HAVE A PACKAGE OF 1000ML APEX BAGS THAT HAVE A CONTAMINANT IN THEM. I THINK IT MAY BE A BUG OR SOME DIRT?
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22895205 ↗
Other CONTAINER, I.V. devices
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- INTRAVIA 2B8012Baxter International Inc. · CONTAINER, I.V.119 reports
- APEX™ 2112531B. Braun Medical Inc. · CONTAINER, I.V.69 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
- SECURE® 66043Metrix Company, The · Container, I.V.1 recall3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.