PINNACLE® 2112349Recalls & reported problems
B. Braun Medical Inc. · PINNACLE® Single Chamber Mixing Container, EVA Formulation, 2000 mL · Class 2
All models of PINNACLE (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04046964200700), received between Jun 25, 2018 and Sep 25, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (12 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 Problem12
- Device Contamination with Chemical or Other Material1
Patient problems
- No Patient Involvement7
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898565 ↗MalfunctionSep 23, 2026Contamination /Decontamination Problem
According to the complainant, prior to use, a hair was observed inside a Pinnacle Single Chamber Mixing Container. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871150 ↗MalfunctionDec 9, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: HI GOOD MORNING, ATTACHING THE PHOTOS OF OUR TPN WITH THE PLENAMINE ADDED. THEY ARE SLIGHTLY MORE YELLOW IN PERSON BUT NOT COMING THROUGH IN THE PHOTOS. THE BAG ON THE LEFT WAS THE BAG WE COMPOUNDED ON (B)(6) AND THE BAG ON THE RIGHT IS THE BAG WE COMPOUNDED YESTERDAY (B)(6). AS MORE TIME PASSES, THE BAGS SEEM TO BE GETTING SLIGHTLY MORE YELLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23756754 ↗MalfunctionJul 29, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE GLOBAL AFFILIATE: PRESENCE OF A CONTAMINANT (HAIR) IN THE BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22641649 ↗MalfunctionMay 23, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
ACCORDING TO THE EVENT DESCRIPTION: DURING THE PARENTERAL NUTRITION QUALITY CHECK, A STAIN WAS IDENTIFIED ON THE PARENTERAL NUTRITION BAG AT THE PORT FOR CONNECTION OF THE ADMINISTRATION EQUIPMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22077441 ↗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 15054528 ↗MalfunctionJan 7, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: DURING COMPOUNDING IT WAS NOTICED THAT THERE WAS A LOOSE PIECE OF PLASTIC INSIDE THE BAG.
Patient problems: No Patient Involvement
MAUDE report 9559992 ↗MalfunctionNov 25, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: BAG HAS A HAIR IN IT. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9371114 ↗MalfunctionNov 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: COMPOUNDED FINAL CONTAINER FOUND WITH PLASTIC IN IT. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9337490 ↗MalfunctionNov 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: COMPOUNDED FINAL CONTAINER FOUND WITH PLASTIC IN IT. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9337488 ↗MalfunctionJul 17, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: ONE BAG HAD CORING INSIDE. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8799484 ↗MalfunctionJul 11, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: BAG HAS A PIECE OF CORING IN IT. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8780034 ↗MalfunctionJun 25, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED BY USER FACILITY: HAIR AND STAINS FOUND INSIDE THE PUNCTURE SITE. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7635348 ↗
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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