INTROCAN SAFETY® 4252561-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963318703), received between May 1, 2019 and Jul 11, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Problem” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2024Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION ULTRASOUND GUIDED IV; A STAFF MEMBER SUSTAINED A NEEDLE STICK AFTER USING THE DEVICE. THERE IS NOT A SAFETY DEVICE ON END OF NEEDLE THAT ENGAGED, DETAILED INQUIRY DESCRIPTION ULTRASOUND GUIDED IV; A STAFF MEMBER SUSTAINED A NEEDLE STICK AFTER USING THIS DEVICE. THERE IS NOT A SAFETY DEVICE ON THE END OF THE NEEDLE THAT IS ENGAGED AFTER USE: THE DEFECTIVE PRODUCT WAS NOT STORED FOR VENDOR INVESTIGATION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 19720113 ↗
• MalfunctionAug 24, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): INCIDENT DETAILS: PATIENT REQUIRED MULTIPLE ATTEMPTS FOR U/S GUIDED 18G IV FOR CT WITH CONTRAST PRIOR TO DIALYSIS. I PLACED AN 18G 2 1/2" IV UNDER ULTRASOUND GUIDANCE WITHOUT COMPLICATIONS BUT THEN NOTICED THE SITE WAS BLEEDING. UPON INVESTIGATION I FOUND THERE WAS A HOLE OR LEAK AT THE BASE OF THE IV CATHETER WHERE THE CATHETER MEETS THE COLORED HUB. WE WERE FORCED TO REMOVE THE IV.IMPACT OF INCIDENT: THE PATIENT WAS UNABLE TO GET CT SCAN PRIOR TO DIALYSIS, MEANING THEY CAN NO LONGER USE CONTRAST AND PATIENT WILL NEED A DIFFERENT TEST TO ASSESS FOR PE. PATIENT ALSO WENT THROUGH A PROCEDURE THEY FOUND UNCOMFORTABLE AND PAINFUL THAT ENDED UP BEING FUTILE BECAUSE THE IV HAD TO BE REMOVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 17620664 ↗
• MalfunctionMay 1, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: HOLE IN CATHETER ABOUT 1 CM FROM HUB OF CATHETER NOTED DURING BLOOD DRAW. CATHETER DISCONTINUED. BLEEDING TO SITE CONTROLLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8570835 ↗