APEX™ 2112528Recalls & reported problems
B. Braun Medical Inc. · EVA Single-Chamber Final Containers 250 mL · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04046964539169), received between Mar 1, 2018 and Jul 1, 2026 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (15 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 Problem15
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DESCRIPTION PARTICULATE MATTER IDENTIFIED DURING INCOMING AQL INSPECTION OF RECEIVED QUANTITY OF APEX SINGLE CHAMBER BAG 250 ML LOT 25C22.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25676811 ↗MalfunctionJun 3, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DURING RAW MATERIAL INSPECTION, 1 PARTICULATE MATTER - MOBILE WAS LOCATED, CAUSING A FAILURE OF RAW MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25375862 ↗MalfunctionApr 22, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DURING RAW MATERIAL INSPECTION, 1 PARTICULATE MATTER - MOBILE WAS LOCATED CAUSING A FAILURE OF RAW MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953950 ↗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 24839098 ↗MalfunctionDec 3, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, DURING RAW MATERIAL INSPECTION, ONE (1) PARTICULATE MATTER WAS OBSERVED IN SOLUTION. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704800 ↗MalfunctionDec 3, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, DURING RAW MATERIAL INSPECTION, ONE (1) PARTICULATE MATTER WAS OBSERVED IN SOLUTION. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704772 ↗MalfunctionNov 25, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: OUR QUALITY TEAM CONDUCTS AN INCOMING VISUAL INSPECTION ON ALL RAW MATERIALS. WE ARE FINDING PARTICULATE MATTER IN THE BAGS AND HAVE REJECTED EVERY LOT# WE HAVE RECEIVED SINCE WE STARTED THIS PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23649767 ↗MalfunctionNov 24, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: OUR QUALITY TEAM CONDUCTS AN INCOMING VISUAL INSPECTION ON ALL RAW MATERIALS. WE ARE FINDING PARTICULATE MATTER IN THE BAGS AND HAVE REJECTED EVERY LOT# WE HAVE RECEIVED SINCE WE STARTED THIS PROCESS. WE CANNOT CONTINUE TO MAKE OUR LIFE SAVING MEDICATIONS WITHOUT MATERIALS THAT PASS OUR INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23633842 ↗MalfunctionNov 24, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: OUR QUALITY TEAM CONDUCTS AN INCOMING VISUAL INSPECTION ON ALL RAW MATERIALS. WE ARE FINDING PARTICULATE MATTER IN THE BAGS AND HAVE REJECTED EVERY LOT# WE HAVE RECEIVED SINCE WE STARTED THIS PROCESS. WE CANNOT CONTINUE TO MAKE OUR LIFE SAVING MEDICATIONS WITHOUT MATERIALS THAT PASS OUR INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23633774 ↗MalfunctionNov 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: WE HAVE INITIATED SCAR-01734 FOR APEX 250 ML SINGLE CHAMBER BAGS. DURING RAW MATERIAL INSPECTION, ONE PARTICULATE MATTER IN SOLUTION WAS LOCATED, CAUSING A FAILURE OF RAW MATERIAL. NC-12663 HAS BEEN INITIATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23535286 ↗MalfunctionNov 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, DURING A RAW MATERIAL INSPECTION OF APEX 250 ML SINGLE CHAMBER BAGS, THREE (3) EMBEDDED PARTICLES WERE LOCATED, CAUSING A FAILURE OF RAW MATERIAL. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23535010 ↗MalfunctionNov 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: WE HAVE INITIATED SCAR-01734 FOR APEX 250 ML SINGLE CHAMBER BAGS. DURING RAW MATERIAL INSPECTION, ONE PARTICULATE MATTER IN SOLUTION WAS LOCATED, CAUSING A FAILURE OF RAW MATERIAL. NC-12482 HAS BEEN INITIATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23532103 ↗MalfunctionNov 10, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: WE HAVE INITIATED B)(4) FOR APEX 250 ML SINGLE CHAMBER BAGS. DURING RAW MATERIAL INSPECTION, ONE EMBEDDED PARTICLE, ONE COSMETIC DEFECT, AND ONE PARTICULATE MATTER IN SOLUTION WAS LOCATED, CAUSING A FAILURE OF RAW MATERIAL. NC-12105 HAS BEEN INITIATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23509448 ↗MalfunctionAug 7, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: WE HAVE RECEIVED PARTICULATE MATTER RESULTS BACK FROM OUR VENDOR, PHOTOMETRICS. UPON EVALUATION, IT IS TO BE NOTATED THAT PROTEIN, SKIN FLAKE WAS FOUND EMBEDDED WITHIN AN APEX 250 ML BAG. DESCRIPTION WHEN PARTICULATE MATTER IS FOUND DURING AQL INSPECTION, IT MUST BE SENT OFFSITE FOR IDENTIFICATION AT PHOTOMETRICS. UPON RECEIPT OF THE PARTICULATE MATTER IDENTIFICATION ON JUL 18, 2025, A SCAR WAS INITIATED DUE TO PROTEIN, SKIN FLAKE PARTICULATE LOCATED EMBEDDED IN THE BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22737444 ↗MalfunctionMay 27, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: ISSUE DESCRIPTION: COMPREHENSIVE TREND INVESTIGATION FOR FAILED AQQL DUE TO PARTICULATE MATTER - SOLUTION EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22088734 ↗MalfunctionMar 1, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED BY USER FACILITY: HAVING ISSUES SPIKING THE BAGS FOR USE, AND AFTER SPIKING WE ARE FINDING RESIDUAL PLASTIC INSIDE THE BAG. NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7307314 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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