APEX™ 2112529Recalls & reported problems
B. Braun Medical Inc. · EVA Single-Chamber Final Containers 500 mL · Class 2
Quick summary
This B. Braun EVA single-chamber IV container is a flexible bag used to hold intravenous fluids. The 31 reports mostly describe contamination found during inspection or storage — loose particles or plastic bits floating in the solution or stuck in the port, dirty ports, and stains inside the bag. No deaths and no injuries were reported, and most involved no patient at all. There are no recalls naming 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
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04046964539121), received between Mar 1, 2018 and Jul 7, 2026 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (30 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 Problem30
- Device Contamination with Chemical or Other Material4
Patient problems
- No Patient Involvement24
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DURING RAW MATERIAL INSPECTION, 1 UNIT WAS IDENTIFIED TO HAVE PARTICULATE MATTER - MOBILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25736954 ↗MalfunctionJul 7, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: ONE UNIT FROM THIS LOT WAS ORIGINALLY REJECTED ON NOV 07, 2025 FOR PARTICULATE MATTER IN SOLUTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25736953 ↗MalfunctionApr 11, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: 500ML FINAL CONTAINERS DIRTY ADD PORTS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24851654 ↗MalfunctionApr 10, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: 3L FINAL CONTAINER PLASTIC PARTICLE IN PACKAGING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24843833 ↗MalfunctionJan 20, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: PLEASE LOOK AT THE ATTACHED PHOTO OF A STRANGE ORANGE STAIN IN THE PORT. THIS ORDER WAS SCRAPPED AND REMADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24121407 ↗MalfunctionSep 30, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: (B)(6) FROM (B)(6) CALLED TO REPORT A SMALL MARK ON THE INNER SIDE OF THE BAG TOWARDS THE BOTTOM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20338427 ↗MalfunctionOct 21, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 1 SMALL WHITE OR TRANSLUCENT FLOATING PARTICULATE FOUND DURING FINAL INSPECTION. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9213827 ↗MalfunctionOct 21, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 3: SMALL WHITE OR TRANSLUCENT FLOATING PARTICULATE FOUND DURING FINAL INSPECTION. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9213825 ↗MalfunctionOct 21, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 2: SMALL WHITE OR TRANSLUCENT FLOATING PARTICULATE FOUND DURING FINAL INSPECTION. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9213822 ↗MalfunctionOct 4, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 2: SMALL WHITE PARTICULATE FLOATING IN THE BAG AFTER COMPOUNDING. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9157058 ↗MalfunctionOct 4, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 1: SMALL WHITE PARTICULATE FLOATING IN THE BAG AFTER COMPOUNDING. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9157055 ↗MalfunctionSep 27, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: FLOATING PARTICULATE FOUND IN FINAL CONTAINER. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9131834 ↗MalfunctionSep 20, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 1. FLOATING PARTICULATE FOUND IN FINAL CONTAINER. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9100972 ↗MalfunctionSep 20, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 2. FLOATING PARTICULATE FOUND IN FINAL CONTAINER. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9100552 ↗MalfunctionSep 20, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 3. FLOATING PARTICULATE FOUND IN FINAL CONTAINER. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9100542 ↗MalfunctionJul 11, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: BLACK PARTICULATE IN FINAL CONTAINER. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8780033 ↗MalfunctionJun 4, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: 'CORES' FOUND AFTER COMPOUNDING, DURING FINAL INSPECTIONS. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8666444 ↗MalfunctionNov 14, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 1. FOUND A WHITE FLOATER IN THE FINAL CONTAINER. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8071211 ↗MalfunctionNov 14, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: FOUND A WHITE FLOATER IN THE FINAL CONTAINER. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8071210 ↗MalfunctionNov 14, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 2. FOUND A WHITE FLOATER IN THE FINAL CONTAINER. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8071209 ↗MalfunctionNov 7, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: FOUND A VERY SMALL WHITE FLOATER IN A 500ML NEONATAL BAG. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8046003 ↗MalfunctionNov 7, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 2: FOUND A VERY SMALL WHITE FLOATER IN A 500ML NEONATAL BAG. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8045986 ↗MalfunctionNov 7, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 1: FOUND A VERY SMALL WHITE FLOATER IN A 500ML NEONATAL BAG. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8045984 ↗MalfunctionOct 31, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 1. VERY SMALL WHITE FLOATER FOUND DURING FINAL INSPECTION. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8025941 ↗MalfunctionOct 31, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: A SMALL WHITE FLOATER WAS FOUND DURING FINAL INSPECTION. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8025936 ↗
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
- APEX™ 2112530B. Braun Medical Inc. · CONTAINER, I.V.66 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.