SURECAN SAFETY II 4447012-02Recalls & reported problems
B. Braun Medical Inc. · Surecan™ Safety II Port Access Needle Set 22G 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046955156320), received between Jul 24, 2019 and Jul 24, 2019 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (4 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
- Break4
Patient problems
- Foreign Body In Patient4
- Needle Stick/Puncture2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 24, 2019Break; Break
AS REPORTED BY USER FACILITY: EVENT 1: NEEDLE BROKE OFF AND REMAINED IN PATIENT'S CHEST/PORT. NURSE HAD A NEEDLE STICK AS THIS OCCURED.
Patient problems: Foreign Body In Patient; Needle Stick/Puncture
MAUDE report 8822583 ↗InjuryJul 24, 2019Break; Break
AS REPORTED BY USER FACILITY: EVENT 1. NEEDLE BROKE OFF AND REMAINED IN PATIENT'S CHEST/PORT. NURSE HAD A NEEDLE STICK AS THIS OCCURED.
Patient problems: Foreign Body In Patient; Needle Stick/Puncture
MAUDE report 8821594 ↗InjuryJul 24, 2019Break; Break
AS REPORTED BY USER FACILITY: EVENT 2. NEEDLE BROKE OFF AND REMAINED IN PATIENT'S CHEST/PORT.
Patient problems: Foreign Body In Patient
MAUDE report 8821592 ↗InjuryJul 24, 2019Break; Break
AS REPORTED BY USER FACILITY: EVENT 2: NEEDLE BROKE OFF AND REMAINED IN PATIENT'S CHEST/PORT.
Patient problems: Foreign Body In Patient
MAUDE report 8821591 ↗
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
- MEDLINE HNX20075Medline Industries, 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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