MEDLINE HNY20075Recalls & reported problems
Medline Industries, Inc. · HUBER INFUSION SET,Y-SITE, 20G X 0. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10197344039852), received between Sep 21, 2026 and Sep 21, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848664 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.