Mini-Spike® 412000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04022495769619), received between Oct 10, 2018 and Oct 28, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2019Improper Flow or Infusion; Improper Flow or Infusion

  PER MEDWATCH NUMBER (B)(4). EVENT DESCRIPTION: IN-PATIENT WAS BROUGHT TO MRI FOR AN ABDOMINAL MRI WITH CONTRAST. MRI POWER INJECTOR WAS FILLED AND PRIMED. PATENCY OF ANTECUBITAL PERIPHERAL INTRAVENOUS LINE WAS CONFIRMED WITH SALINE INJECTION AND THE PERIPHERAL IV LINE WAS CONNECTED TO THE AUTOMATED CONTRAST-INJECTOR. AFTER MR IMAGING WAS PERFORMED, THE TECHNOLOGIST NOTICED THAT THERE WAS NO SIGN OF CONTRAST-ADMINISTRATION ON OBTAINED IMAGES. THE PATIENT WAS EVALUATED AND WAS NOT SYMPTOMATIC, AND NO INFILTRATION OF CONTRAST WAS IDENTIFIED IN THE SOFT TISSUES. WHEN THE CONTRAST-INJECTOR SYRINGE WAS EVALUATED, AIR WAS NOTED IN THE SYRINGE THAT SHOULD HAVE CONTAINED CONTRAST MATERIAL. IT WAS THEREFORE ASSUMED THAT AN INJECTION OF 10CC OF AIR INTO THE PERIPHERAL INTRAVENOUS LINE HAD OCCURRED. AT APPROXIMATELY 0815, THE ATTENDING NEURORADIOLOGIST, WAS NOTIFIED. THE PATIENT WAS REMOVED FROM THE MRI ROOM, EVALUATED AND PLACED IN A LEFT-SIDE DOWN DECUBITUS AND IN TRENDELENBURG (HEAD-DOWN) POSITION. WHILE IN THE MRI DEPARTMENT FOR THE NEXT 45 MINUTES, BLOOD PRESSURE, HEART RATE AND PULSE OXIMETRY WERE MONITORED AND REMAINED STABLE. THE PATIENT WAS ASYMPTOMATIC. THE ATTENDING MEURORADIOLOGIST

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9244992 ↗
• MalfunctionOct 10, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: WHEN THE CUSTOMER INSERTED THE DISPENSING PIN INTO THE BOTTLE, LEAKAGE OCCURRED FROM THE DISPENSING PIN. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7953676 ↗