Mini-Spike® 412012Recalls & reported problems
B. Braun Medical Inc. · MINI-SPIKE® IV Additive Dispensing Pin · Class 2
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04022495769671), received between Jul 3, 2018 and May 12, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (14 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 Problem14
- Device Contamination with Chemical or Other Material1
- Device-Device Incompatibility1
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Known Impact Or Consequence To Patient3
- Chemical Exposure1
- No Patient Involvement1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: THE MINI-SPIKE DISPENSING PIN NOT USED DUE TO VISIBLE CONTAMINATION IN THE FLUID PATH. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25147910 ↗MalfunctionFeb 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DURING COMPOUNDING 1 MINI SPIKE WAS FOUND WITH A PARTICLE IN THE SPIKE TIP. THE FENTANYL VIAL HAD BEEN SPIKED AND DRAINED AND WHEN CHANGED THE PARTICLE WAS FOUND. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21431984 ↗MalfunctionFeb 13, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DURING COMPOUNDING 1 MINI SPIKE WAS FOUND WITH A PARTICLE IN THE SPIKE TIP. THE FENTANYL VIAL HAD BEEN SPIKED AND DRAINED AND WHEN CHANGED THE PARTICLE WAS FOUND. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21378421 ↗MalfunctionJan 10, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: "A PIECE OF PLASTIC OF THE SPIKE CAP BROKE AND ENDED UP IN A SALINE SYRINGE. LUCKILY, IT WAS DISCOVERED BEFORE HOOKING IT TO THE PATIENT. THE DRUG HAS BEEN WASTED." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21129698 ↗MalfunctionJan 26, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: MINI-SPIKE DISPENSING PIN - LEAKAGE. DETAILED INQUIRY DESCRIPTION: PREPARED VIALS AS PER USUAL, AIR WAS NOT ADDED, WHEN VIAL WAS FLIPPED TO WITHDRAWAL INTO SYRINGE WE HAD LEAKAGE INTO FILTER OF THE DISPENSING PIN. OCCURRED WITH CETUXIMAB 100MG/50ML VIAL. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18586803 ↗MalfunctionNov 16, 2023Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility
AS REPORTED BY THE USER FACILITY: DURING 100% BLACK/WHITE BOX VISUAL INSPECTION ON (B)(6) 2023 PHARMACIST FOUND ONE BAG TO HAVE A WHITE FLOATING PARTICLE INSIDE. DRUG HAD BEEN ADDED TO THE BAG. PER BATCH RECORD INSTRUCTION THE MINI SPIKE IS CHANGED ABOUT EVERY 20 SPIKES. WE TESTED A FEW SPIKES INTO THE STOPPER AFTER COMPOUNDING AND DID NOTICE VISIBLE MARKINGS ON THE SPIKE AFTER WITHDRAWAL FROM THE VIAL. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18147685 ↗MalfunctionSep 1, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: WHILE INSPECTING COMPONENTS ONE OF THE MINI SPIKE WAS FOUND TO HAVE BLACK SPECK SEALED WITHIN THE CAP. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17673313 ↗MalfunctionMay 15, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DETAILS OF ISSUE: THERE APPEARS TO BE CONTAMINATE ON OR IN THE DISPENSING PIN SPIKE CAP. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16935611 ↗MalfunctionFeb 24, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION PRODUCT WAS OBSERVED DIRTY UPON REMOVING FROM BOX. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13595809 ↗MalfunctionDec 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: AS PER EMAIL: "ONE OF MY TECHNICIANS FOUND THE VIAL SPIKE WITH BLACK DOTS ON IT IN OUR CLEANROOM." NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12956944 ↗MalfunctionAug 11, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT BROWN RESIDUE WAS OBSERVED ON THE SPIKE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12306405 ↗MalfunctionJun 29, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: CUSTOMER STATES THAT THERE IS MOLD, OR MAYBE DRIED BLOOD, VISIBLE INSIDE THE SPIKE IN THE INTACT BLISTER PACK. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12084197 ↗MalfunctionJun 1, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT WHEN THE END USER INVERTED THE VIAL TO CHECK THE INTEGRITY, SOME OF THE CHEMOTHERAPY LEAKED ONTO THE THUMB OF HER RIGHT HAND. NO INJURY REPORTED.
Patient problems: Chemical Exposure
MAUDE report 10104920 ↗MalfunctionFeb 18, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT MOLD AND DIRT WERE SEEN WITHIN THE PACKAGING. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9720672 ↗MalfunctionDec 12, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT AFTER DRAWING UP PROPOFOL INTO A SYRINGE USING B. BRAUN 412012 DISPENSING PIN, SMALL BLUE PARTICLES WERE SEEN FLOATING IN THE PROPOFOL. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9457822 ↗MalfunctionDec 12, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT AFTER DRAWING UP PROPOFOL INTO A SYRINGE USING B. BRAUN 412012 DISPENSING PIN, SMALL BLUE PARTICLES WERE SEEN FLOATING IN THE PROPOFOL. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9457801 ↗MalfunctionJul 3, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED BY THE USER FACILITY: FOREIGN MATTER WAS SEEN INSIDE THE PROTECTIVE CAP OF THE DISPENSING PIN. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7661584 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.