PINNACLE® 2112348Recalls & reported problems
B. Braun Medical Inc. · PINNACLE® Single Chamber Mixing Container, EVA Formulation, 1000 mL · Class 2
All models of PINNACLE (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04046964200670), received between May 8, 2018 and Mar 24, 2026 — classified as 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (9 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 Problem9
- Adverse Event Without Identified Device or Use Problem1
- Air/Gas in Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient2
- No Patient Involvement2
- Sprain1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: FOREIGN MATTER WAS FOUND IN THE FLUID PATH. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24675106 ↗MalfunctionMar 2, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: A SMALL PARTICULATE WAS IDENTIFIED IN A CERTAIN LOT OF PINNACLE 1L BAGS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482225 ↗MalfunctionDec 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
FOREIGN MATTER FLUID PATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23853341 ↗MalfunctionNov 13, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, FIBERS WERE FOUND INSIDE BAG. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23544827 ↗MalfunctionJul 30, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: WITH THIS LOT NUMBER, EXPIRES 4/7/28 THE ARTERIAL LINE IS GETTING A LOT OF AIR AS SOON AS IT IS HOOKED UP TO THE FISTULA OR CVC (CENTRAL VENOUS LINE). THERE ARE AIR BUBBLES AT THAT CONNECTION EVEN THOUGH THE USER IS MAKING SURE TO LOCK THE DEVICE IN. THE CONNECTION IS NOT JOINING PROPERLY. AS THE DEVICES WERE ATTACHED TO A PATIENT - NONE OF THE FAILING PRODUCT IS AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22666368 ↗MalfunctionJan 21, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORT PARTICLE INSIDE THE BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13314950 ↗MalfunctionDec 10, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 2. PLASTIC PARTICLE FOUND IN THE PORT. NO PATIENT INVOLVEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9446054 ↗MalfunctionDec 10, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 1. WHITE PLASTIC PARTICULATE FOUND IN FLUID. NO PATIENT INVOLVEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9446041 ↗MalfunctionAug 21, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 2. FOREIGN MATERIAL NOTICED UNDER DEVICE CAP BEFORE COMPOUNDING. WHILE TRYING TO TAKE PICTURES OF THE FOREIGN MATTER, THE FOREIGN MATTER MIGRATED INTO THE DEVICE TUBING.
Patient problems: No Patient Involvement
MAUDE report 7800834 ↗MalfunctionAug 21, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 1 FOREIGN MATERIAL NOTICED FLOATING IN COMPOUNDED SOLUTION.
Patient problems: No Patient Involvement
MAUDE report 7800826 ↗InjuryMay 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY USER FACILITY: THE FACILITY HAS CONTINUAL PRODUCT USE WITH REPETITIVE SPIKING, CONSTANT ELBOW MOVEMENT, HAND AND WRIST TWISTING. THE CONCERN WITH SPIKING THIS BAG IS THAT THE SPIKE PORT NEEDS TO BE SPIKED DEEPER OR IT WILL OCCLUDE. PUSHING THE SPIKE IN DEEPER REPETITIVELY IS CAUSING STRAIN ON EMPLOYEES ALL DAY LONG. ONE EMPLOYEE IN PARTICULAR EXPERIENCED RIGHT ELBOW PAIN AND NUMBNESS IN HER HAND. PHYSICAL THERAPY WAS TRIED, BUT THE DISCOMFORT CONTINUED. EVENTUALLY THIS EMPLOYEE NEEDED SURGERY. EMPLOYEE HAD AN ULNAR NERVE RIGHT ELBOW NEUROPLASTY ON (B)(6) 2018.
Patient problems: Sprain
MAUDE report 7494760 ↗
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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