SURECAN SAFETY II 4447010-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964858130), received between Nov 4, 2021 and Nov 4, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2021Fail-Safe Problem; Device Handling Problem; Fail-Safe Problem; Device Handling Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1. CUSTOMER REPORTS THAT THE PASSIVE SAFETY SHIELD FAILED TO ENGAGE ALL THE WAY AND RESULTED IN A NEEDLESTICK INJURY. CUSTOMER STATES IT HAPPENED TWICE TO TWO DIFFERENT CLINICIANS (SAME LOT NUMBER).

  Patient problems: Needle Stick/Puncture

  MAUDE report 12752368 ↗
• MalfunctionNov 4, 2021Fail-Safe Problem; Device Handling Problem; Fail-Safe Problem; Device Handling Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2. CUSTOMER REPORTS THAT THE PASSIVE SAFETY SHIELD FAILED TO ENGAGE ALL THE WAY AND RESULTED IN A NEEDLESTICK INJURY. CUSTOMER STATES IT HAPPENED TWICE TO TWO DIFFERENT CLINICIANS (SAME LOT NUMBER).

  Patient problems: Needle Stick/Puncture

  MAUDE report 12752364 ↗