INTROCAN SAFETY® 4254503-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04046963318314), received between Jan 8, 2018 and Feb 11, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Break

  AS REPORTED BY THE USER FACILITY: ISSUE: PLASTIC PORTION THAT REMAINS IN THE VEIN IS FRYING. SPLIT DOWN THE MIDDLE AND OPENED. PATIENT INJURY NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317668 ↗
• MalfunctionSep 25, 2024Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2 BRIEF INQUIRY DESCRIPTION CLIP DID NOT ENGAGE ON INTROCAN DETAILED INQUIRY DESCRIPTION WE HAVE HAD A FEW ISSUES WITH THE INTROCAN SAFETY IV CATHETER WINGED-FEP WHERE THE SAFETY FEATURE HAS FAILED. I HAVE HAD ONE NURSE THAT THIS HAS HAPPENED ON 2 OCCASIONS, THE FIRST ONE SHE FORGOT TO GET A PICTURE OF THE NEEDLE, BUT TOOK A PICTURE OF THE PACKAGE. THE SECOND TIME IT HAPPENED, SHE CALLED ME OVER SO I COULD TAKE A PICTURE OF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305606 ↗
• MalfunctionSep 25, 2024Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1: BRIEF INQUIRY DESCRIPTION. CLIP DID NOT ENGAGE ON INTROCAN. DETAILED INQUIRY DESCRIPTION: WE HAVE HAD A FEW ISSUES WITH THE INTROCAN SAFETY IV CATHETER WINGED-FEP WHERE THE SAFETY FEATURE HAS FAILED. I HAVE HAD ONE NURSE THAT THIS HAS HAPPENED ON 2 OCCASIONS, THE FIRST ONE SHE FORGOT TO GET A PICTURE OF THE NEEDLE, BUT TOOK A PICTURE OF THE PACKAGE. THE SECOND TIME IT HAPPENED, SHE CALLED ME OVER SO I COULD TAKE A PICTURE OF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305565 ↗
• MalfunctionDec 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: SET DETACHED AND PATIENT LOST 2 ML OF BLOOD.

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 9418770 ↗
• MalfunctionDec 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 2: IN THE NICU, A T CONNECTOR SEPARATED FROM A YELLOW ANGIOCATH, RESULTING IN BLOOD LEAKAGE. THIS DID NOT HAPPEN UNTIL A FEW DAYS AFTER THE IV BEGAN RUNNING, SO PACKAGING WITH LOT INFORMATION WAS ALREADY DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9406039 ↗
• MalfunctionDec 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 3: IN THE NICU, A T CONNECTOR SEPARATED FROM A YELLOW ANGIOCATH, RESULTING IN BLOOD LEAKAGE. THIS DID NOT HAPPEN UNTIL A FEW DAYS AFTER THE IV BEGAN RUNNING, SO PACKAGING WITH LOT INFORMATION WAS ALREADY DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9406037 ↗
• MalfunctionDec 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 1: IN THE NICU, A T CONNECTOR SEPARATED FROM A YELLOW ANGIOCATH, RESULTING IN BLOOD LEAKAGE. THIS DID NOT HAPPEN UNTIL A FEW DAYS AFTER THE IV BEGAN RUNNING, SO PACKAGING WITH LOT INFORMATION WAS ALREADY DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9406030 ↗
• MalfunctionJan 8, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: IV CATHETER WAS BEING INSERTED AND BENT AND BROKE, SO EVEN THOUGH THE IV STICK WAS SUCCESSFUL, THE IV HAD TO BE TAKEN OUT BECAUSE IT WAS LEAKING BLOOD FROM THE BROKEN CATHETER. PATIENT HAD TO BE RESTUCK. IV FLUID ADMINISTRATION WAS DELAYED FOR THREE (3) HOURS. OTHERWISE, NO REPORT OF PATIENT INJURY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 7173600 ↗