SURECAN SAFETY II 4447005-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046964857935), received between Aug 9, 2019 and Feb 5, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2021Fail-Safe Problem; Device Handling Problem; Fail-Safe Problem; Device Handling Problem

  AS REPORTED BY USER FACILITY: THE RN WAS REMOVING IT FROM THE PATIENT'S PORT POST INFUSION AND THE SAFETY DID NOT FULLY ENGAGE (SO THE NEEDLE WAS STILL EXPOSED). HER RIGHT THUMB WAS SCRATCHED BY THE NEEDLE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11285821 ↗
• MalfunctionAug 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 2: AFTER FLUSHING THE NEEDLE/CATHETER AND INSERTING INTO THE PATIENT'S ACCESS PORT, BLOOD WAS LEAKING AT THE JUNCTION OF THE DEVICE HUB AND THE NEEDLE WHEN THE NURSE ATTEMPTED TO WITHDRAW BLOOD TO VERIFY PLACEMENT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10408761 ↗
• MalfunctionAug 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 1: AFTER FLUSHING THE NEEDLE/CATHETER AND INSERTING INTO THE PATIENT'S ACCESS PORT, BLOOD WAS LEAKING AT THE JUNCTION OF THE DEVICE HUB AND THE NEEDLE WHEN THE NURSE ATTEMPTED TO WITHDRAW BLOOD TO VERIFY PLACEMENT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10408754 ↗
• MalfunctionAug 9, 2019Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: EVENT 2: THE SAFETY MECHANISM DID NOT ENGAGE WHEN DEACCESSING THE PORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8878644 ↗
• MalfunctionAug 9, 2019Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: EVENT 1: THE SAFETY MECHANISM DID NOT ENGAGE WHEN DEACCESSING THE PORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8878640 ↗
• MalfunctionAug 9, 2019Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: EVENT 3: THE SAFETY MECHANISM DID NOT ENGAGE WHEN DEACCESSING THE PORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8878639 ↗