PINNACLE® 2112350Recalls & reported problems
B. Braun Medical Inc. · PINNACLE® Single Chamber Mixing Container, EVA Formulation, 3000 mL · Class 2
All models of PINNACLE (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04046964200793), received between Jan 16, 2020 and Sep 25, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem10
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Patient Involvement1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Contamination /Decontamination Problem
As reported by the user facility:I am just reaching out to let you guys know that we have stumbled upon our 3L TPN B-Braun bags having blue fibers in them!
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898562 ↗MalfunctionAug 8, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE B. BRAUN GLOBAL AFFILIATE: EVENT 4: WHEN DID THE FAILURE OCCUR: BEFORE APPLICATION. REASON OF COMPLAINT: PRESENCIA DE CONTAMINANTE (CABELLO). PRESENCE OF CONTAMINANT (HAIR).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22751619 ↗MalfunctionAug 8, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE B. BRAUN GLOBAL AFFILIATE: EVENT 1: WHEN DID THE FAILURE OCCUR: BEFORE APPLICATION. REASON OF COMPLAINT: PRESENCIA DE CONTAMINANTE (CABELLO). PRESENCE OF CONTAMINANT (HAIR).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22751618 ↗MalfunctionAug 8, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE B. BRAUN GLOBAL AFFILIATE: EVENT 3 WHEN DID THE FAILURE OCCUR: BEFORE APPLICATION REASON OF COMPLAINT: PRESENCIA DE CONTAMINANTE (CABELLO) PRESENCE OF CONTAMINANT (HAIR).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22751617 ↗MalfunctionAug 8, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE B. BRAUN GLOBAL AFFILIATE: EVENT 5: WHEN DID THE FAILURE OCCUR: BEFORE APPLICATION. REASON OF COMPLAINT: PRESENCIA DE CONTAMINANTE (CABELLO). PRESENCE OF CONTAMINANT (HAIR).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22751616 ↗MalfunctionAug 8, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE B. BRAUN GLOBAL AFFILIATE: EVENT 2: WHEN DID THE FAILURE OCCUR: BEFORE APPLICATION. REASON OF COMPLAINT: PRESENCIA DE CONTAMINANTE (CABELLO). PRESENCE OF CONTAMINANT (HAIR).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22751615 ↗MalfunctionJul 19, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: BLACK SPECK INSIDE CONTAINER. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15054538 ↗MalfunctionMar 11, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2 FOREIGN SUBSTANCE IN TPN BAG AFTER COMPOUNDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731818 ↗MalfunctionMar 11, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1 FOREIGN SUBSTANCE IN TPN BAG AFTER COMPOUNDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731817 ↗MalfunctionJan 16, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: BLUE FIBER IN BAG AFTER COMPOUNDING.
Patient problems: No Patient Involvement
MAUDE report 9597806 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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