SURECAN SAFETY II 4447051-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046955156399), received between Mar 16, 2020 and May 12, 2022 — classified as 3 malfunctions.

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

• MalfunctionMay 12, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: THE NURSE ACCESSED THE PATIENT'S PORT WITH THE NEW 20G PORT NEEDLES. WHEN THE NURSE DREW BACK, BLOOD IMMEDIATELY BEGAN SEEPING AROUND THE NEEDLE AND RUNNING DOWN THE PATIENT'S CHEST. IT REQUIRED THE NURSE TO REMOVE THE NEEDLE AND APPLY LIGHT PRESSURE FOR 30 SECONDS AND RE-ACCESS PORT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 14371671 ↗
• MalfunctionJan 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  I ACCESSED THE ABOVE PATIENT'S PORT WITH THE NEW 20G PORT NEEDLES. WHEN I DREW BACK, BLOOD IMMEDIATELY BEGAN SEEPING AROUND THE NEEDLE AND RUNNING DOWN THE PATIENT'S CHEST. IT REQUIRED ME TO REMOVE THE NEEDLE AND APPLY LIGHT PRESSURE FOR 30 SECONDS AND RE-ACCESS PORT.

  Patient problems: Extravasation

  MAUDE report 13383751 ↗
• MalfunctionMar 16, 2020Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: THE SAFETY MECHANISM DID NOT ENGAGE WHICH RESULTED IN THE PATIENT'S SKIN TEARING.

  Patient problems: Skin Tears

  MAUDE report 9834547 ↗