PINNACLE® 2112351Recalls & reported problems
B. Braun Medical Inc. · PINNACLE® Single Chamber Mixing Container, EVA Formulation, 4000 mL · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964200823), received between Apr 7, 2020 and Apr 24, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (4 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 Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, DURING INCOMING RAW MATERIAL INSPECTION, ONE (1) PARTICULATE MATTER WAS OBSERVED IN A PINNACLE 4000 MILLILITER (ML) EVA MIXING CONTAINER. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24987160 ↗MalfunctionDec 3, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DURING RAW MATERIAL INSPECTION, TWO PARTICULATE MATTER EMBEDDED DEFECTS WERE LOCATED, CAUSING A FAILURE OF RAW MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23703850 ↗MalfunctionOct 11, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: WE ALSO HAVE A B. BRAUN EVA MIXING CONTAINER THAT HAS A BLACK SPOT IN THE MIDDLE PORT. THIS BAG WAS USED TO MIX A TPN IN AND THEN THE SPOT WAS VISIBLE, SO WE DID NOT UTILIZE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17911967 ↗MalfunctionApr 7, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: A HUMAN HAIR WAS FOUND IN A COMPOUNDING BAG. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9932703 ↗
Other CONTAINER, I.V. devices
- INTRAVIA 2B8011Baxter International Inc. · CONTAINER, I.V.127 reports
- 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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