SURECAN SAFETY II 4447006-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04046955156276), received between May 17, 2018 and Dec 29, 2021 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2021Device Handling Problem; Device Handling Problem

  AS REPORTED BY THE USER FACILITY: 2 NEEDLESTICKS OCCURRED WITH STAFF- ONE WITH CLEAN NEEDLE WHILE TRYING TO REATTACH THE BASEPLATE. ONE WAS WITH NEEDLE THAT HAD BEEN ACCESSED. IT IS REPORTED THAT NURSE STUCK HERSELF WHEN TRYING TO READJUST THE NEEDLE. IT IS UNKNOWN IF THE NEEDLE WAS CLEAN OR HAD ALREADY BEEN USED AT THE TIME OF INJURY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 13112631 ↗
• MalfunctionDec 8, 2021Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: THE SURECAN NEEDLE DID NOT LOCK IN PLACE RESULTING IN NEEDLESTICK FOR RN.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12963139 ↗
• MalfunctionMay 11, 2020Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: AFTER DEACCESSING A PORT-A-CATH, THE PORT NEEDLE SAFETY ENGAGED, BUT DID NOT FULLY LOCK INTO PLACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10043332 ↗
• MalfunctionApr 15, 2020Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: NEEDLE REMOVED FROM PATIENT AND SAFETY FEATURE MALFUNCTIONED AND CAME OFF DURING REMOVAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9961810 ↗
• MalfunctionOct 22, 2019Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: WHEN REMOVED FROM THE PORT THE SAFETY DID NOT ENGAGE. NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9219525 ↗
• MalfunctionMay 17, 2018Fail-Safe Problem

  AS REPORTED BY USER FACILITY: EVENT 1 WHEN THE TECHNICIAN WAS REMOVING THE HUBER NEEDLE FROM THE PATIENT, THE SAFETY MECHANISM DID NOT ACTIVATE. THE SAFETY MECHANISM SLIDES TO THE BOTTOM OF THE NEEDLE BUT DOESN'T ENGAGE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7522517 ↗
• MalfunctionMay 17, 2018Fail-Safe Problem

  AS REPORTED BY USER FACILITY: UPON DE-ACCESSING A PATIENT'S PORT, SURECAN SAFETY DID NOT ENGAGE AND CLINICIAN OBTAINED A NEEDLE STICK INJURY. CLINICIAN AND THE SOURCE PATIENT WERE BOTH TESTED FOR (B)(6). CURRENT STATUS OF THE CLINICIAN IS HEALTHY.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 7522515 ↗
• MalfunctionMay 17, 2018Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: EVENT 1: WHEN THE TECHNICIAN WAS REMOVING THE HUBER NEEDLE FROM THE PATIENT, THE SAFETY MECHANISM DID NOT ACTIVATE. THE SAFETY MECHANISM SLIDES TO THE BOTTOM OF THE NEEDLE BUT DOESN'T ENGAGE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7522513 ↗
• MalfunctionMay 17, 2018Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: EVENT 3: WHEN THE TECHNICIAN WAS REMOVING THE HUBER NEEDLE FROM THE PATIENT, THE SAFETY MECHANISM DID NOT ACTIVATE. THE SAFETY MECHANISM SLIDES TO THE BOTTOM OF THE NEEDLE BUT DOESN'T ENGAGE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7522508 ↗
• MalfunctionMay 17, 2018Fail-Safe Problem

  AS REPORTED BY USER FACILITY: EVENT 3: WHEN THE TECHNICIAN WAS REMOVING THE HUBER NEEDLE FROM THE PATIENT, THE SAFETY MECHANISM DID NOT ACTIVATE. THE SAFETY MECHANISM SLIDES TO THE BOTTOM OF THE NEEDLE BUT DOESN'T ENGAGE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7522503 ↗
• MalfunctionMay 17, 2018Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: EVENT 2 WHEN THE TECHNICIAN WAS REMOVING THE HUBER NEEDLE FROM THE PATIENT, THE SAFETY MECHANISM DID NOT ACTIVATE. THE SAFETY MECHANISM SLIDES TO THE BOTTOM OF THE NEEDLE BUT DOESN'T ENGAGE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7522502 ↗
• MalfunctionMay 17, 2018Fail-Safe Problem

  AS REPORTED BY USER FACILITY: EVENT 2: WHEN THE TECHNICIAN WAS REMOVING THE HUBER NEEDLE FROM THE PATIENT, THE SAFETY MECHANISM DID NOT ACTIVATE. THE SAFETY MECHANISM SLIDES TO THE BOTTOM OF THE NEEDLE BUT DOESN'T ENGAGE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7522498 ↗
• MalfunctionMay 17, 2018Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: UPON DE-ACCESSING A PATIENT'S PORT, SURECAN SAFETY DID NOT ENGAGE AND CLINICIAN OBTAINED A NEEDLE STICK INJURY. CLINICIAN AND THE SOURCE PATIENT WERE BOTH TESTED FOR (B)(6 AND (B)(6). CURRENT STATUS OF CLINICIAN IS HEALTHY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 7522496 ↗