INTROCAN SAFETY® 4252551-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963318192), received between Mar 9, 2021 and Jun 19, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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.

• InjuryJun 19, 2026Break

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: "IV WAS STARTED IN ER ON (B)(6) 2023. UNSURE OF LOT NUMBER; HOWEVER, WE BELIEVE IT WAS A BRAUN BRAND 18-GAUGE CATHETER 1 3/4 INCH." DETAILED INQUIRY DESCRIPTION: "IT WAS REPORTED THAT ON (B)(6) 2023 A 18GA 1.75IN IV CATHETER BROKE IN A PATIENTS ARM WHILE BEING REMOVED. THE PATIENT HAD TO BE TRANSPORTED TO SURGERY TO HAVE THE DEVICE REMOVED. AS PART OF AN INTERNAL NONCONFORMANCE, THIS IMPORTER MDR IS BEING SUBMITTED RETROACTIVELY. PLEASE NOTE THAT THE ASSOCIATED MANUFACTURER MDR FOR THIS EVENT, 9610825-2023-00614, HAD ALREADY BEEN PREVIOUSLY SUBMITTED TIMELY ON 18DEC2023. AS B. BRAUN MEDICAL, INC. SUBMITTED THE MANUFACTURER MDR ON BEHALF OF THE MANUFACTURER, THE IMPORTER MDR WAS INADVERTENTLY MISSED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25563496 ↗
• InjuryDec 18, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: "IV WAS STARTED IN ER ON (B)(6) 2023. UNSURE OF LOT NUMBER; HOWEVER, WE BELIEVE IT WAS A BRAUN BRAND 18-GAUGE CATHETER 1 3/4 INCH." DETAILED INQUIRY DESCRIPTION: "IT WAS REPORTED THAT ON (B)(6) 2023 A 18GA 1.75IN IV CATHETER BROKE IN A PATIENTS ARM WHILE BEING REMOVED. THE PATIENT HAD TO BE TRANSPORTED TO SURGERY TO HAVE THE DEVICE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18347206 ↗
• MalfunctionMar 9, 2021Break; Break

  AS REPORTED ON MW (B)(4): WHILE PLACING AN ULTRASOUND GUIDED PERIPHERAL IV, THE ATTEMPT WAS UNSUCCESSFUL AND THE CATHETER WAS REMOVED, THAT IS WHEN IT WAS DISCOVERED THAT THE END OF THE CATHETER WAS NOT INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11446733 ↗