MEDLINE HNX20075Recalls & reported problems
Medline Industries, Inc. · HUBER NEEDLE,NO Y-SITE,20G X 0.75 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10197344039760), received between Nov 14, 2024 and Sep 30, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
- Break2
- Detachment of Device or Device Component1
Patient problems
- Extravasation2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950995 ↗MalfunctionSep 23, 2026Break; Detachment of Device or Device Component
It was reported that "Needle came out from plastic base upon safety activation, and wing broke off on one."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871812 ↗MalfunctionNov 15, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
HUBER NEEDLE DISLODGMENT FROM PORT SITE CAUSING CHEMO EXTRAVASATION.
Patient problems: Extravasation
MAUDE report 20695263 ↗MalfunctionNov 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
HUBER NEEDLE DISLODGMENT FROM PORT SITE CAUSING CHEMO EXTRAVASATION.
Patient problems: Extravasation
MAUDE report 20689298 ↗
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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