Port Access Needle SHG20-100Recalls & reported problems
Bard Access Systems, Inc. · EZ Huber 20ga 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
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741089169), received between Jan 2, 2020 and Jan 26, 2023 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak3
- Activation Problem2
- Defective Component1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Needle Stick/Puncture1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2023Material Deformation; Material Deformation
IT WAS REPORTED ¿NEEDLE SHOWS SEVERE BENDING." NO OTHER INFORMATION WAS PROVIDED. 01/20/2023 - THE RETURNED SAMPLE EXHIBITED A BEND. THE SAFETY COULD NOT BE ADVANCED OVER THE BENT REGION OF THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16247373 ↗InjuryApr 7, 2022Activation Problem; Activation Problem
IT WAS REPORTED THAT PULLING THE PORT NEEDLE THROUGH THE SAFETY CANNULA RESULTED IN A NEEDLESTICK INJURY TO THE RIGHT INDEX FINGER OF THE USER. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Needle Stick/Puncture
MAUDE report 14043429 ↗MalfunctionFeb 25, 2022Activation Problem; Activation Problem
IT WAS REPORTED THAT WHEN THE NEEDLE WAS PULLED, THE SAFETY MECHANISM DISENGAGED FROM THE RETAINING PLATE. THIS MEANS THERE IS A RISK THAT EMPLOYEES WILL POKE THEMSELVES OR THAT CHEMOTHERAPY DRUGS WILL LEAK OUT UNINTENTIONALLY. THE DEFECTIVE NEEDLE WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13602267 ↗MalfunctionFeb 16, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BLOOD WITHDRAWAL VIA PORT, AFTER THE BLOOD WITHDRAWAL WAS FINISHED AND THE TUBE WAS FLUSHED AND BLOCKED WITH POSITIVE PRESSURE, A DROP OF BLOOD WAS HANGING AT THE TRANSITION FROM TUBE TO NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13544290 ↗MalfunctionJan 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "PATIENT PORT ACCESSED W/20 G X 1¿ BARD HUBER NEEDLE, HAD A LEVAQUIN INFUSING FLUID LEAKING FROM TUBING, NOTED 1 IN HUBER NEEDLE CRACKED, PORT ACCESSED ON (B)(6) 2021. PT REFUSED VAL-GUARD; NEED TO USE TEDDY BEARS WHEN LINE NOT INFUSING. WASN¿T ABLE TO SEND UNTIL CULTURES WERE NEGATIVE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13308959 ↗MalfunctionJan 2, 2020Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component
IT WAS REPORTED THAT THE CLAMP ON THE DEVICE WAS LEAKING. THE NEEDLE WAS PLACED 3 DAYS PRIOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9541046 ↗
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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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