Mini-Spike® 412004Recalls & reported problems
B. Braun Medical Inc. · MINI-SPIKE® Dispensing Pin with Security Clip · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963497484), received between Aug 26, 2019 and Jan 15, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (3 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 Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionAug 26, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: THE MINI-SPIKE HAS A FOREIGN MATERIAL ON TOP OF THE SPIKE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8930864 ↗
Other Set, i.V. Fluid transfer devices
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- EXACTAMIX H938738Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,180 reports
- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
- EXACTAMIX H938741Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall710 reports
- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 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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