Mini-SpikeRecalls & reported problems across all models

We found 3 models of Mini-Spike by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Jul 3, 2018 and May 12, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Mini-Spike problems

Mini-Spike models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Mini-Spike® 412012

  Set, i.V. Fluid transfer
  17 reports
• Mini-Spike® 412004

  Set, i.V. Fluid transfer
  3 reports
• Mini-Spike® 412000

  Set, administration, intravascular
  2 reports

Recent Mini-Spike adverse event reports

The 15 most recent reports across all models, 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 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: WHEN OPENING THE PRODUCT NOTICED THERE IS A DARK/BLACK RING ON THE INSIDE OF THE DISPENSING SPIKE. WHEN WE TRIED TO RUB ON IT WITH A PAPER CLIP IT CAME OFF. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158821 ↗
• 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 22, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: A RED FIBER WAS OBSERVED WITHIN THE FINAL PRODUCT BAG. DUE TO THE NATURE OF THE MANUFACTURING PROCESS, ONE OF MANY MATERIALS/CONSUMABLES USED COULD HAVE INTRODUCED THIS PARTICULATE. [CUSTOMER IS] REACHING OUT TO SEVERAL SUPPLIERS.

  Patient problems: No Patient Involvement

  MAUDE report 10179988 ↗
• 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 ↗

Other B. Braun Medical Inc. products

• Infusomat54 models · 2,783 reports · 30 recalls
• IV Administration Set153 models · 281 reports · 68 recalls
• Hemodialysis Bloodlines9 models · 2,179 reports · 14 recalls
• Outlook25 models · 195 reports · 24 recalls
• Perifix57 models · 224 reports · 20 recalls
• Extension Set41 models · 101 reports · 16 recalls
• Design Options116 models · 132 reports · 14 recalls
• Blood Administration Set24 models · 177 reports · 13 recalls