APEX™ 2112532Recalls & reported problems
B. Braun Medical Inc. · EVA Single-Chamber Final Containers 3000 mL · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This B. Braun APEX EVA single-chamber IV container is a flexible bag used for holding or mixing intravenous fluids. The 35 reports all describe contamination found when the bag or its injection port is opened — white or black specks inside the chamber, a brown spot on a port cap, or a contaminated port. None mention a patient being harmed, and there were no deaths or injuries. 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
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 04046964539220), received between Jun 4, 2019 and Jun 19, 2026 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (35 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 Problem35
Patient problems
- No Patient Involvement18
- No Clinical Signs, Symptoms or Conditions17
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: I HAVE 1 APEX EVA MIXING CONTAINER 3 LITER BAG AND IT HAS A WHITE FOREIGN MATTER INSIDE THE BAG AND I WOULD LIKE TO REPORT THAT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25563841 ↗MalfunctionApr 22, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTING UPON OPENING THE FIRST BAG OF A 5 PACK THEY NOTICED ONE OF THE PORT CAPS HAS A BROWN SPOT THAT LOOKS LIKE A SMALL WORM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953888 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
THE COMPLAINANT REPORTS THAT THE INJECTION PORT IS CONTAMINATED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257236 ↗MalfunctionMar 14, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 3 BRIEF INQUIRY DESCRIPTION 10 3L APEX FINAL CONTAINERS LOT 24L04 - BLACK SPECS INSIDE THE CHAMBERS - OUT OF BOX FAILURE - DISPOSABLE RETURN. ISSUE(S) REPORTED: (B)(6) REPORTED THAT SHE RECEIVED 2 PACKAGES OF 3L FINAL CONTAINERS WHERE THERE ARE BLACK SPECS INSIDE THE CONTAINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606199 ↗MalfunctionMar 14, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1 BRIEF INQUIRY DESCRIPTION 10 3L APEX FINAL CONTAINERS LOT 24L04 - BLACK SPECS INSIDE THE CHAMBERS - OUT OF BOX FAILURE - DISPOSABLE RETURN. ISSUE(S) REPORTED: STEPHANIE REPORTED THAT SHE RECEIVED 2 PACKAGES OF 3L FINAL CONTAINERS WHERE THERE ARE BLACK SPECS INSIDE THE CONTAINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606195 ↗MalfunctionMar 14, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2 BRIEF INQUIRY DESCRIPTION 10 3L APEX FINAL CONTAINERS LOT 24L04 - BLACK SPECS INSIDE THE CHAMBERS - OUT OF BOX FAILURE - DISPOSABLE RETURN. ISSUE(S) REPORTED: (B)(6) REPORTED THAT SHE RECEIVED 2 PACKAGES OF 3L FINAL CONTAINERS WHERE THERE ARE BLACK SPECS INSIDE THE CONTAINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606188 ↗MalfunctionMar 14, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 6: BRIEF INQUIRY DESCRIPTION: 10 3L APEX FINAL CONTAINERS LOT 24L04 - BLACK SPECS INSIDE THE CHAMBERS - OUT OF BOX FAILURE - DISPOSABLE RETURN. ISSUE(S) REPORTED: (B)(6) REPORTED THAT SHE RECEIVED 2 PACKAGES OF 3L FINAL CONTAINERS WHERE THERE ARE BLACK SPECS INSIDE THE CONTAINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606187 ↗MalfunctionMar 14, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 4 BRIEF INQUIRY DESCRIPTION 10 3L APEX FINAL CONTAINERS LOT 24L04 - BLACK SPECS INSIDE THE CHAMBERS - OUT OF BOX FAILURE - DISPOSABLE RETURN. ISSUE(S) REPORTED: STEPHANIE REPORTED THAT SHE RECEIVED 2 PACKAGES OF 3L FINAL CONTAINERS WHERE THERE ARE BLACK SPECS INSIDE THE CONTAINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606185 ↗MalfunctionMar 14, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 10 BRIEF INQUIRY DESCRIPTION 10 3L APEX FINAL CONTAINERS LOT 24L04 - BLACK SPECS INSIDE THE CHAMBERS - OUT OF BOX FAILURE - DISPOSABLE RETURN. ISSUE(S) REPORTED: (B)(6) REPORTED THAT SHE RECEIVED 2 PACKAGES OF 3L FINAL CONTAINERS WHERE THERE ARE BLACK SPECS INSIDE THE CONTAINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606183 ↗MalfunctionMar 14, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 7. BRIEF INQUIRY DESCRIPTION. 10 3L APEX FINAL CONTAINERS LOT 24L04 - BLACK SPECS INSIDE THE CHAMBERS - OUT OF BOX FAILURE - DISPOSABLE RETURN. ISSUE(S) REPORTED: (B)(6) REPORTED THAT SHE RECEIVED 2 PACKAGES OF 3L FINAL CONTAINERS WHERE THERE ARE BLACK SPECS INSIDE THE CONTAINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606182 ↗MalfunctionMar 14, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 5. BRIEF INQUIRY DESCRIPTION: 10 3L APEX FINAL CONTAINERS LOT: 24L04 - BLACK SPECS INSIDE THE CHAMBERS - OUT OF BOX FAILURE - DISPOSABLE RETURN. ISSUE(S) REPORTED: (B)(6) REPORTED THAT SHE RECEIVED 2 PACKAGES OF 3L FINAL CONTAINERS WHERE THERE ARE BLACK SPECS INSIDE THE CONTAINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606178 ↗MalfunctionMar 14, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 9 BRIEF INQUIRY DESCRIPTION 10 3L APEX FINAL CONTAINERS LOT 24L04 - BLACK SPECS INSIDE THE CHAMBERS - OUT OF BOX FAILURE - DISPOSABLE RETURN. ISSUE(S) REPORTED: (B)(6) REPORTED THAT SHE RECEIVED 2 PACKAGES OF 3L FINAL CONTAINERS WHERE THERE ARE BLACK SPECS INSIDE THE CONTAINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606175 ↗MalfunctionMar 14, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 8 BRIEF INQUIRY DESCRIPTION 10 3L APEX FINAL CONTAINERS LOT 24L04 - BLACK SPECS INSIDE THE CHAMBERS - OUT OF BOX FAILURE - DISPOSABLE RETURN. ISSUE(S) REPORTED: (B)(6) REPORTED THAT SHE RECEIVED 2 PACKAGES OF 3L FINAL CONTAINERS WHERE THERE ARE BLACK SPECS INSIDE THE CONTAINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606174 ↗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 19689063 ↗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 19689053 ↗MalfunctionApr 16, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION CUSTOMER REPORTING ISSUE WITH 3L FINAL CONTAINER WHEN SPIKED - BROWN SUBSTANCE OBSERVED IN PORT - DISPOSABLE RETURN DETAILED INQUIRY DESCRIPTION PER (B)(6) EMAIL: " THIS IS ONE SITUATION THAT I HAVE NOT OBSERVED IN THE PAST. PATIENT STATED THEY HAD A BLACKISH RING AT THE SPIKE PORT OF THE TPN BAG. WE TOLD THEM NOT TO USE OR TO DO ANYTHING TO THE BAG AND WE WOULD SEND A COURIER TO PICK UP. WHEN WE RECEIVED THE BAG THERE WAS A DARK REDDISH BROWN RING, VERY SMALL, IN THE SPIKE PORT THAT ALSO CONTAINED AIR. IT APPEARED DRY LIKE SOME TOOK A REDDISH BROWN MARKER AND MADE A LINE CIRCLE ON THE INSIDE OF THE SPIKE PORT TUBE. THEN WHEN THIS BAG WAS MANIPULATED TO SQUEEZE OUT AIR FROM THAT PORT AREA AND SOLUTION WAS ALLOWED TO CONTACT THAT RED/BROWN LINE IT WENT INTO SOLUTION AND PRODUCED THE DISCOLORED SOLUTION YOU CAN SEE IN THE PHOTO BELOW. I HAVE ATTACHED THE CAR FOR THIS SPECIFIC BAG. THIS WAS OBSERVED BY (B)(6) FLOAT TECH AND SINCE (B)(6) IS ALSO HERE I HAD HIM TAKE A LOOK AS WELL. MY THOUGHT IS THAT A VERY SMALL AMOUNT OF AMINO ACID GOT IN THAT AIR LOCKED PORT LOCATION AND OXIDIZED BUT I AM NOT SURE HOW THAT COULD HAPPEN AS I
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19114849 ↗MalfunctionAug 11, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: BLACK SPOT OBSERVED ON ADDITIVE PORT; APPEARS TO BE EMBEDDED IN THE RUBBER OF THE PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12306219 ↗MalfunctionNov 21, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: SMALL, HARD, WHITE SLIVER WAS FOUND INSIDE THE FINAL CONTAINER. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9356078 ↗MalfunctionJun 24, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: FLOATING PARTICULATES FOUND IN FINAL CONTAINER. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8727809 ↗MalfunctionJun 24, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: FLOATING PARTICULATES FOUND IN FINAL CONTAINER. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8727807 ↗MalfunctionJun 14, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: CORING ISSUE; PARTICULATE IN FINAL CONTAINER. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8699242 ↗MalfunctionJun 14, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: CORING ISSUE; PARTICULATE IN FINAL CONTAINER. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8699241 ↗MalfunctionJun 14, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: FLOATING PARTICULATES FOUND IN FINAL CONTAINER. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8699234 ↗MalfunctionJun 14, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: FLOATING PARTICULATES FOUND IN FINAL CONTAINER. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8699230 ↗MalfunctionJun 4, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 8: 'CORES' FOUND AFTER COMPOUNDING, DURING FINAL INSPECTIONS. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8666476 ↗
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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