Port Access Needle 012234Recalls & reported problems
Bard Access Systems, Inc. · HuberPlus 22G x .75" · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741065712), received between Nov 21, 2018 and Sep 24, 2020 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (9 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
- Material Deformation9
- Problem with Sterilization6
- Packaging Problem4
- Activation Problem1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Known Impact Or Consequence To Patient10
- No Patient Involvement3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2020Material Deformation; Activation Problem; Material Deformation; Activation Problem
IT WAS REPORTED THAT DURING REMOVAL, THE SAFETY MECHANISM COULD NOT BE ACTIVATED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10583811 ↗MalfunctionNov 21, 2018Material Deformation; Packaging Problem
IT WAS REPORTED THE DEVICE PACKAGE WAS DEFORMED ON 14 DEVICES (THE STERILITY OF DEVICE WAS SUSPECTED TO BE NOT IN GOOD CONDITION). DEVICES WERE NOT USED ON PATIENTS. THIS REPORT ADDRESSES THE NINTH DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8095717 ↗MalfunctionNov 21, 2018Material Deformation; Packaging Problem
IT WAS REPORTED THE DEVICE PACKAGE WAS DEFORMED ON 14 DEVICES (THE STERILITY OF DEVICE WAS SUSPECTED TO BE NOT IN GOOD CONDITION). DEVICES WERE NOT USED ON PATIENTS. THIS REPORT ADDRESSES THE 13TH DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8095710 ↗MalfunctionNov 21, 2018Problem with Sterilization
IT WAS REPORTED THE DEVICE PACKAGE WAS DEFORMED ON 14 DEVICES (THE STERILITY OF DEVICE WAS SUSPECTED TO BE NOT IN GOOD CONDITION). DEVICES WERE NOT USED ON PATIENTS. THIS REPORT ADDRESSES THE 11TH DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8095709 ↗MalfunctionNov 21, 2018Problem with Sterilization
IT WAS REPORTED THE DEVICE PACKAGE WAS DEFORMED ON 14 DEVICES (THE STERILITY OF DEVICE WAS SUSPECTED TO BE NOT IN GOOD CONDITION). DEVICES WERE NOT USED ON PATIENTS. THIS REPORT ADDRESSES THE FIFTH DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8095708 ↗MalfunctionNov 21, 2018Problem with Sterilization
IT WAS REPORTED THE DEVICE PACKAGE WAS DEFORMED ON 14 DEVICES (THE STERILITY OF DEVICE WAS SUSPECTED TO BE NOT IN GOOD CONDITION). DEVICES WERE NOT USED ON PATIENTS. THIS REPORT ADDRESSES THE FOURTH DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8095707 ↗MalfunctionNov 21, 2018Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THE DEVICE PACKAGE WAS DEFORMED ON 14 DEVICES (THE STERILITY OF DEVICE WAS SUSPECTED TO BE NOT IN GOOD CONDITION). DEVICES WERE NOT USED ON PATIENTS. THIS REPORT ADDRESSES THE 12TH DEVICE.
Patient problems: No Patient Involvement
MAUDE report 8095706 ↗MalfunctionNov 21, 2018Material Deformation; Packaging Problem
IT WAS REPORTED THE DEVICE PACKAGE WAS DEFORMED ON 14 DEVICES (THE STERILITY OF DEVICE WAS SUSPECTED TO BE NOT IN GOOD CONDITION). DEVICES WERE NOT USED ON PATIENTS. THIS REPORT ADDRESSES THE TENTH DEVICE.
Patient problems: No Patient Involvement
MAUDE report 8095703 ↗MalfunctionNov 21, 2018Problem with Sterilization; Material Deformation
IT WAS REPORTED THE DEVICE PACKAGE WAS DEFORMED ON 14 DEVICES (THE STERILITY OF DEVICE WAS SUSPECTED TO BE NOT IN GOOD CONDITION). DEVICES WERE NOT USED ON PATIENTS. THIS REPORT ADDRESSES THE 14TH DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8095701 ↗MalfunctionNov 21, 2018Material Deformation; Packaging Problem
IT WAS REPORTED THE DEVICE PACKAGE WAS DEFORMED ON 14 DEVICES (THE STERILITY OF DEVICE WAS SUSPECTED TO BE NOT IN GOOD CONDITION). DEVICES WERE NOT USED ON PATIENTS. THIS REPORT ADDRESSES THE SIXTH DEVICE.
Patient problems: No Patient Involvement
MAUDE report 8095699 ↗MalfunctionNov 21, 2018Material Deformation
IT WAS REPORTED THE DEVICE PACKAGE WAS DEFORMED ON 14 DEVICES (THE STERILITY OF DEVICE WAS SUSPECTED TO BE NOT IN GOOD CONDITION). DEVICES WERE NOT USED ON PATIENTS. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8095697 ↗MalfunctionNov 21, 2018Problem with Sterilization
IT WAS REPORTED THE DEVICE PACKAGE WAS DEFORMED ON 14 DEVICES (THE STERILITY OF DEVICE WAS SUSPECTED TO BE NOT IN GOOD CONDITION). DEVICES WERE NOT USED ON PATIENTS. THIS REPORT ADDRESSES THE SEVENTH DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8095693 ↗MalfunctionNov 21, 2018Material Deformation
IT WAS REPORTED THE DEVICE PACKAGE WAS DEFORMED ON 14 DEVICES (THE STERILITY OF DEVICE WAS SUSPECTED TO BE NOT IN GOOD CONDITION). DEVICES WERE NOT USED ON PATIENTS. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8095597 ↗MalfunctionNov 21, 2018Problem with Sterilization; Material Deformation
IT WAS REPORTED THE DEVICE PACKAGE WAS DEFORMED ON 14 DEVICES (THE STERILITY OF DEVICE WAS SUSPECTED TO BE NOT IN GOOD CONDITION). DEVICES WERE NOT USED ON PATIENTS. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8095592 ↗
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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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