Port Access Needle 012034NYRecalls & reported problems
Bard Access Systems, Inc. · HuberPlus 20G x .75" with Y-Site and Needless Injection Site · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Access Systems HuberPlus port access needle is a hubbed port access set. Reports mostly describe torn packaging and some deformed valves that leak or affect sterility. There are 77 adverse event reports, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 77
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00801741065637), received between Mar 29, 2019 and Jul 20, 2022 — classified as 77 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (69 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 16, 2026.
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging69
- Problem with Sterilization4
- Fluid/Blood Leak3
- Material Deformation3
- Failure to Infuse1
- Peeled/Delaminated1
Patient problems
- No Patient Involvement70
- No Known Impact Or Consequence To Patient5
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2022Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT THE NEEDLE CAN'T RETURN BLOOD AND THE BOLUS RESISTANCE IS LARGE. PATIENT STATUS/ INTERVENTION: CHANGE NEW NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15066333 ↗MalfunctionJun 24, 2020Fluid/Blood Leak; Fluid/Blood Leak
ON 08 JUNE 2020: IT WAS REPORTED THE Y POINT OF THE GRIPER IS DEFECTIVE, WHICH WHEN PURGING IT SELLS THE LIQUID THROUGH THE BIOCONNECTOR OF THE Y POINT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 10192955 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 38 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072926 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 36 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072916 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 34 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072915 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 40 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072914 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 39 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072913 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 35 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072912 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 32 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072911 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 37 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072910 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 33 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072909 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 30 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072867 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 29 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072866 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 31 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072865 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 27 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072864 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 28 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072863 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 25 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072850 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 26 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072849 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 24 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072847 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 18 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072846 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 21 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072704 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 23 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072702 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 22 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072701 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 17 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072700 ↗MalfunctionMay 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING IS DEFORMED, WHICH LEADS TO THE LOSS OF STERILITY OF CERTAIN NEEDLES. IT WAS STATE THAT THE VALVE ON THE Y-SITE IS ALSO DEFORMED CAUSING LEAKING. IT WAS STATED THIS OCCURRED WITH 40 NEEDLES. THIS REPORT ADDRESSES 19 OF 40.
Patient problems: No Patient Involvement
MAUDE report 10072696 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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