APEX™ 2112531Recalls & reported problems
B. Braun Medical Inc. · EVA Single-Chamber Final Containers 2000 mL · Class 2
Quick summary
This B. Braun APEX single-chamber IV container is a flexible bag used to hold intravenous solutions. Most of the 69 reports describe contamination or particle matter found inside the bag or in the rubber additive port — specks, black particles, and reddish or white flakes — with facilities declining to use affected bags. No deaths and no injuries were reported. 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
- 69
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 04046964539206), received between Jun 6, 2018 and Apr 6, 2026 — classified as 69 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (68 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 Problem68
- Device Contamination with Chemical or Other Material1
Patient problems
- No Patient Involvement44
- No Clinical Signs, Symptoms or Conditions23
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: SOMETHING IN THE ADD PORT, NOT SURE WHAT IT IS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792936 ↗MalfunctionDec 3, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION 2112531 LOT 25D14 SPECK INSIDE RUBBER PART OF ADDITIVE PORT. (B)(6) REPORTED A 2L FINAL CONTAINER HAS A SPECK INSIDE RUBBER PART OF ADDITIVE PORT, WHICH THEY DO NOT WANT TO USE BECAUSE OF POTENTIAL CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23706808 ↗MalfunctionNov 24, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: INSIDE THE POUCH BLACK PARTICLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23633955 ↗MalfunctionNov 24, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: INSIDE THE POUCH BLACK PARTICLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23633938 ↗MalfunctionNov 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: WE HAVE ADDED ANOTHER LOT OF RAW MATERIAL TO SCAR-01725 FOR APEX 2000 ML SINGLE CHAMBER BAGS. DURING RAW MATERIAL INSPECTION, ONE PARTICULATE WAS FOUND IN SOLUTION, A WHITE FLAKE, CAUSING A FAILURE OF RAW MATERIAL. NC-12145 HAS BEEN INITIATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23536105 ↗MalfunctionNov 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: WE HAVE ADDED ANOTHER LOT OF RAW MATERIAL TO (B)(6) FOR APEX 2000 ML SINGLE CHAMBER BAGS. DURING RAW MATERIAL INSPECTION, TWO EMBEDDED PARTICLES, REDDISH IN COLOR WERE LOCATED, CAUSING A FAILURE OF RAW MATERIAL. (B)(6) HAS BEEN INITIATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534904 ↗MalfunctionNov 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: WE HAVE INITIATED SCAR-01725 FOR APEX 2000 ML SINGLE CHAMBER BAGS. DURING RAW MATERIAL INSPECTION, TWO EMBEDDED PARTICLES, REDDISH IN COLOR WERE LOCATED, CAUSING A FAILURE OF RAW MATERIAL. NC-12101 HAS BEEN INITIATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23532093 ↗MalfunctionNov 11, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: WE HAVE ADDED ANOTHER LOT OF RAW MATERIAL TO SCAR-01725 FOR APEX 2000 ML SINGLE CHAMBER BAGS. DURING RAW MATERIAL INSPECTION, ONE PARTICULATE WAS FOUND IN SOLUTION, A CLEAR FLAKE, CAUSING A FAILURE OF RAW MATERIAL. NC-12360 HAS BEEN INITIATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23525792 ↗MalfunctionSep 18, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, BLACK PARTICULATE WAS FOUND ON THE PORT WHERE THE BAG HOOKS UP TO THE MACHINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23082975 ↗MalfunctionSep 2, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: A HAIR WAS NOTICED IN THE TPN BAG AFTER IT HAS BEEN COMPOUNDED. BAG WAS STILL AT THE CAPS FACILITY AND HAS NOT BEEN SENT TO CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22930013 ↗MalfunctionMar 7, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: PRODUCT REF#: 2112531, LOT#: 24H27, REPORTED ISSUE: HAIR INSIDE BAG, QUANTITY AFFECTED: 1, ANY INJURY OR HARM: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21551695 ↗MalfunctionFeb 18, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
THE COMPLAINANT REPORTED THAT A BLACK PARTICLE WAS OBSERVED IN THE ADMINISTRATION PORT OF A 2000 MILLILITER (ML) APEX SINGLE CHAMBER BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21394666 ↗MalfunctionJul 8, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: I WOULD LIKE TO REPORT THAT CAPS LAS VEGAS HAS FOUND SEVERAL SEALED EVA MIXING CONTAINER PACKETS WITH PARTICLES INSIDE, WHICH COMPROMISES STERILITY AND RENDERS THE BAGS UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19689105 ↗MalfunctionJul 8, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: I WOULD LIKE TO REPORT THAT CAPS LAS VEGAS HAS FOUND SEVERAL SEALED EVA MIXING CONTAINER PACKETS WITH PARTICLES INSIDE, WHICH COMPROMISES STERILITY AND RENDERS THE BAGS UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19689042 ↗MalfunctionFeb 21, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: REPORTER CALLED TO REPORT UPON OPENING THE PACKAGING THERE WAS A HAIR FOUND INSIDE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18746933 ↗MalfunctionFeb 5, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: I JUST WANTED TO REACH OUT TO LET YOU KNOW OUR STAFF NOTICED A FOREIGN PARTICLE INSIDE THE 2L BAG. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18639152 ↗MalfunctionNov 2, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A HAIR WAS DISCOVERED, POSSIBLY AN "EYELASH HAIR" IN THE INSIDE ONE OF THE 2L SINGLE CHAMBER FINAL CONTAINERS AFTER ON ORDER HAD BEEN COMPOUNDED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15713381 ↗MalfunctionJun 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: VIAL CORING AND THE GRAY PIECE OF PLASTIC FROM THE PORT MADE IT ALL THE WAY INTO THE FINAL TPN CONTAINER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11948452 ↗MalfunctionMay 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2: HAIR FOUND IN THE PORT OF THE BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11824448 ↗MalfunctionMay 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1: HAIR FOUND IN THE PORT OF THE BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11824447 ↗MalfunctionDec 7, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: FINAL CONTAINER FOUND TO HAVE A PARTICLE INSIDE THE BAG DURING THE INITIAL INSPECTION PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10958651 ↗MalfunctionDec 7, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: FINAL CONTAINER FOUND TO HAVE A PARTICLE INSIDE THE BAG DURING THE INITIAL INSPECTION PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10958646 ↗MalfunctionSep 9, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: HAIR DISCOVERED IN INJECTION PORT OF 2L SINGLE CHAMBER FINAL CONTAINER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10507087 ↗MalfunctionJul 15, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: BROWN SPECKS ON THE BAG, WHERE THE TUBING IS ATTACHED.
Patient problems: No Patient Involvement
MAUDE report 10275401 ↗MalfunctionApr 15, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: ONE OF OUR TECHS FOUND TWO (2) HAIRS SEALED IN THE BAG. IT LOOKS LIKE IT IS SEALED IN THE PORT AND THE SADDLE. SOME OF IT IS OUTSIDE OF THE SEALED AREA AND SOME IS INSIDE.
Patient problems: No Patient Involvement
MAUDE report 9961813 ↗
Other CONTAINER, I.V. devices
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- INTRAVIA 2B8012Baxter International Inc. · CONTAINER, I.V.119 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
- 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.