Port Access Needle 012005Recalls & reported problems
Bard Access Systems, Inc. · HuberPlus 20G x .5" · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741065576), received between Feb 15, 2019 and Feb 15, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Crack2
- Leak/Splash2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2019Crack; Leak/Splash
IT WAS REPORTED THAT THE EXTENSION TUBING HUB OF THE HUBER PORT ACCESS NEEDLE IS CRACKING AND LEAKING CHEMOTHERAPY. NO INJURY TO PATIENT. IT WAS STATED TWO FROM THIS BATCH HAVE DONE THIS. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8346243 ↗MalfunctionFeb 15, 2019Crack; Leak/Splash
IT WAS REPORTED THAT THE EXTENSION TUBING HUB OF THE HUBER PORT ACCESS NEEDLE IS CRACKING AND LEAKING CHEMOTHERAPY. NO INJURY TO PATIENT. IT WAS STATED TWO FROM THIS BATCH HAVE DONE THIS. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8346223 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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