Port Access Needle SHG19-100Recalls & reported problems
Bard Access Systems, Inc. · EZ Huber 19ga x 1in · Class 2
All models of Port Access Needle (122)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741089077), received between Apr 1, 2021 and Dec 5, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Activation Problem” (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. 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
- Activation Problem1
- Fluid/Blood Leak1
- Material Deformation1
Patient problems
- Exposure to Body Fluids1
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2023Activation Problem; Activation Problem
IT WAS REPORTED THAT THE NEEDLE GUARD CAME LOOSE WHEN THE PORT WAS PULLED OUT AND THE EMPLOYEE PRICKED HERSELF SUPERFICIALLY. IMMEDIATE ACTION TAKEN BY THE HOSPITAL / CARETAKER RELEVANT TO THE CARE OF THE PATIENT. WOUND DISINFECTED AND NEEDLE SEPARATED. THE INCIDENT HAPPENED AFTER USE ON A PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Exposure to Body Fluids; Needle Stick/Puncture
MAUDE report 18271575 ↗MalfunctionApr 1, 2021Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
IT WAS REPORTED LEAK WAS NOTED AT THE LUER LOCK CONNECTION POINT. THE USERS ALSO FOUND THAT IF A 3-WAY VALVE IS INSTALLED BETWEEN THE CANNULA AND THE INFUSION LINE, THERE IS NO LONGER ANY LEAKAGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11605452 ↗
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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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