Dispensing Pin 413504Recalls & reported problems
B. Braun Medical Inc. · MINI-SPIKE® Dispensing Pin with ULTRASITE® Valve and Security Clip · Class 2
All models of Dispensing Pin (6)
Data updated Oct 16, 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 04046964183195), received between Feb 22, 2021 and Feb 22, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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.
Most reported problems
Device problems
- Contamination /Decontamination Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 22, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
EVENT 2: AS REPORTED BY THE USER FACILITY: THE CLINICIAN WAS USING THE VENTED VIAL ADAPTER (SPIKE) TO PUNCTURE A TREPROSTINIL VIAL. WHEN IT PUNCTURED, ONLY THE TIP OF THE SPIKE WENT INTO THE BOTTLE. IT DID CLAMP ONTO THE BOTTLE, BUT THE CLINICIAN COULD NOT PULL THE MEDICATION OUT OF THE VIAL. FURTHER ATTEMPTS WERE MADE TO RE-SPIKE THE VIAL, CAUSING PARTICULATE MATTER TO FALL INTO THE DRUG VIAL. A NEW SPIKE AND NEW VIAL OF MEDICATION WERE USED AND NO FURTHER DIFFICULTIES WERE NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11362038 ↗MalfunctionFeb 22, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
EVENT 1: AS REPORTED BY THE USER FACILITY: THE CLINICIAN WAS USING THE VENTED VIAL ADAPTER (SPIKE) TO PUNCTURE A TREPROSTINIL VIAL. WHEN IT PUNCTURED, ONLY THE TIP OF THE SPIKE WENT INTO THE BOTTLE. IT DID CLAMP ONTO THE BOTTLE, BUT THE CLINICIAN COULD NOT PULL THE MEDICATION OUT OF THE VIAL. FURTHER ATTEMPTS WERE MADE TO RE-SPIKE THE VIAL, CAUSING PARTICULATE MATTER TO FALL INTO THE DRUG VIAL. A NEW SPIKE AND NEW VIAL OF MEDICATION WERE USED AND NO FURTHER DIFFICULTIES WERE NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11361993 ↗
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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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