LAMIS 14ga x 15cm Infiltration Cannula BN1406Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00081317022527), received between Feb 20, 2019 and Oct 21, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2024Break; Break

  IT WAS REPORTED THAT A LAMIS 14GA X 15CM INFILTRATION CANNULA BROKE DURING AN UNSPECIFIED PROCEDURE. IT WAS THE FIRST TIME THE CANNULA WAS USED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493935 ↗
• MalfunctionSep 22, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT A HUNSTAD INFILTRATION CANNULA WAS FOUND TO BE LEAKING AT THE HUB BY THE END USER. THE REPORT INDICATES THAT THE CANNULA BROKE WHILE INFILTRATING. THE DEVICE WAS NOT IN USE AT THE TIME, AND THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12513103 ↗
• MalfunctionFeb 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LAMIS 14GA X 15CM INFILTRATION CANNULA WAS LEAKING PRIOR TO SURGERY. AFTER THE HANDLE WAS REPLACED BY THE FACILITY, THE CANNULA STARTED LEAKING MORE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8355222 ↗