SURECAN SAFETY II 4447007-02Recalls & reported problems
B. Braun Medical Inc. · Surecan™ Safety II Port Access Needle Set 20G x 1 in. (25mm) · Class 2
All models of SURECAN SAFETY II (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046955156283), received between May 15, 2019 and Aug 14, 2020 — classified as 3 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
Device problems
- Protective Measures Problem3
- Fluid/Blood Leak1
Patient problems
- No Known Impact Or Consequence To Patient2
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2020Fluid/Blood Leak; Protective Measures Problem; Fluid/Blood Leak; Protective Measures Problem
AS REPORTED ON MEDWATCH MW5095237: SAFETY DEVICE ON HUBER NEEDLE DID NOT STAY ENGAGED ON NEEDLE TIP, WHICH CAUSED A NEEDLE STICK WHEN PLACING THE DEVICE IN THE SHARPS CONTAINER.
Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10408763 ↗MalfunctionAug 15, 2019Protective Measures Problem; Protective Measures Problem
AS REPORTED BY USER FACILITY: THE SAFETY DID NOT CLICK AND THE NEEDLE WAS JUST EXPOSED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8897224 ↗MalfunctionMay 15, 2019Protective Measures Problem; Protective Measures Problem
THE NURSES OF THE ONCOLOGY DEPARTMENT HAVE EXPERIENCED SEVERAL TIMES, DIFFICULTIES TO RELEASE THE SAFETY MECHANISM OF THE NEEDLE DURING RETRIEVAL. THIS COULD CAUSE ACCIDENTAL BLOOD EXPOSURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8613928 ↗
Other Non-Coring (Huber) Needle devices
- SafeStep CPA00049Bard Access Systems, Inc. · Non-Coring (Huber) Needle1 recall0 reports
- SafeStep CPA00040Bard Access Systems, Inc. · Non-Coring (Huber) Needle1 recall0 reports
- SafeStep CPA00042ABard Access Systems, Inc. · Non-Coring (Huber) Needle1 recall0 reports
- INTERA AP-07014USIntera Oncology Inc. · Non-Coring (Huber) Needle37 reports
- SURECAN SAFETY II 4447006-02B. Braun Medical Inc. · Non-Coring (Huber) Needle13 reports
- SURECAN SAFETY II 4447005-02B. Braun Medical Inc. · Non-Coring (Huber) Needle6 reports
- AllPoints Port Access System SafeStep AN152075MBard Access Systems, Inc. · Non-coring (Huber) needle5 reports
- SURECAN SAFETY II 4447012-02B. Braun Medical Inc. · Non-Coring (Huber) Needle4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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