INTROCAN SAFETY® 4251644-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04046964398971), received between Jan 12, 2018 and Nov 27, 2024 — classified as 1 death, 2 injuries, 5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Fail-Safe Problem; Fail-Safe Problem

  ACCORDING TO THE CUSTOMER: "NURSE INSERTED IVC AND TOOK BLOODS FROM PATIENT. WHEN CLEANING UP POST-PROCEDURE (WEARING GLOVES), B BRAUN INTROCAN SAFETY 20G CANNULA STABBED R) POINTER FINGER (BROKEN SKIN AND BLOOD PRESENT AT SITE OF NEEDLE PENETRATION), NOTED THAT THE SAFETY FEATURE FAILED TO ACTIVATE. DISPOSED OF FAULTY IVC IN SHARPS CONTAINER, PERFORMED FIRST AID, INFECTION CONTROL NOTIFIED".

  Patient problems: Exposure to Body Fluids

  MAUDE report 20791985 ↗
• MalfunctionMar 2, 2024Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE INTROCAN SAFETY PUR 20G, 1.1X32MM-US WHILE BEING USED ON A PATIENT WERE "BENDY" DURING INSERTION ON PATIENT AND SHATTERED DURING USE. THE EMERGENCY DEPARTMENT HAS REPORTED THAT THE 20-GAUGE INTROSCAN SAFETY IV CATHETER LOT NUMBER 0061864777 HAS BEEN KINKING IN PATIENTS DURING THE CATHETER INSERTION AND OCCASIONALLY SHREDDING WHEN PULLING THE NEEDLE OUT OF THE CATHETER. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18823286 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE: CATHETER-INFECTION

  Patient problems: Inflammation

  MAUDE report 8516317 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE: CATHETER-INFECTION

  Patient problems: Inflammation

  MAUDE report 8516312 ↗
• DeathApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE: CATHETER-INFECTION CATHETER PLACED ON (B)(6) 2019 AND WITHDRAWN ON (B)(6) 2019. THE CATHETER WAS MAINTAINED WITH A TEGADERM DRESSING. THE PATIENT WAS RE-HOSPITALIZED ON (B)(6) 2019 WITH PHLEBITIS. ON (B)(6) 2019 THE PATIENT DEVELOPED SEPSIS AND WAS TRANSFERRED TO THE ICU. THE PATIENT DIED ON (B)(6) 2019.

  Patient problems: Death; Sepsis

  MAUDE report 8516311 ↗
• MalfunctionFeb 26, 2019Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN SPAIN): SECURITY SYSTEM DOESN´T WORK PROPERTELY

  Patient problems: Needle Stick/Puncture

  MAUDE report 8370318 ↗
• MalfunctionJul 13, 2018Break; Break

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN HONG KONG: CATHETER IN ARTERY LINE WAS BROKEN

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7687097 ↗
• MalfunctionJan 12, 2018Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE: NEEDLE-DYSFUNCTION-PRICK

  Patient problems: Needle Stick/Puncture

  MAUDE report 7185530 ↗