PINNACLE® 2112347Recalls & reported problems
B. Braun Medical Inc. · PINNACLE® Single Chamber Mixing Container, EVA Formulation, 500 mL · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964200618), received between Nov 20, 2018 and Sep 29, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).
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.
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): ETOPOSIDE BAG LEAKING FROM MIDDLE PORT OF BOTTOM OF BAG. CYTOTOXIC MEDICATION DRIPPING SLOWLY FROM BAG. FROM PHARMACY MANAGER: THE BAG IS SPIKED WITH A CHEMOCLAVE SPIKE FOR CIRCLE PRIMING. THE SPIKE IS VERY SHARP SO WHEN THE BAG IS FOLDED OVER OR HANDLED ROUGHLY, THE SPIKE CAN PUNCTURE THE BAG. WHEN WE PREPARE THE BAG, STAFF ARE REQUIRED TO CHECK THE INTEGRITY OF THE FINAL PREPARATION TO ENSURE THAT THERE ARE NO LEAKS/PUNCTURES. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15501753 ↗MalfunctionNov 20, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: PHARMACIST WAS COMPOUNDING 8ML OF NITROPRUSSIDE (SAGENT MNFCTR) INTO 234ML OF DEXTROSE 5 PERCENT (BAXTER MNFCTR), THEN ADDED 8ML OF SODIUM THIOSULFATE (HOPE PHARMACEUTICALS). PREPARED THE INFUSION AND SENT TO THE NURSING UNIT IN AN AMBER BAG TO PROTECT FROM LIGHT UNTIL USE. WHEN THE NURSE REMOVED THE COMPOUNDED BAG FROM THE AMBER BAG, THE EVA BAG WAS BLUE. THE NITROPRUSSIDE AND SODIUM THIOSULFATE IN D5 WATER SOLUTION TURNED BLUE; NOT THE BAG ITSELF. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8089126 ↗
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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