Port Access Needle SHG20-75Recalls & reported problems
Bard Access Systems, Inc. · EZ Huber 20ga x 3/4in · Class 2
All models of Port Access Needle (122)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741089237), received between Aug 8, 2019 and Apr 21, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak2
- Material Twisted/Bent2
- Defective Component1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "NEEDLE SHOWS BENDING AFTER OPENING THE PACKAGE. THE EZ HUBER NEEDLE COULDN'T THEN BE USED." IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE. (B)(6) 2023 - DURING EVALUATION OF THE RETURNED DEVICE, AN ATTEMPT TO ADVANCE THE SAFETY WAS UNSUCCESSFUL DUE TO THE BEND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16792067 ↗MalfunctionApr 21, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "NEEDLE SHOWS BENDING AFTER OPENING THE PACKAGE. THE EZ HUBER NEEDLE COULDN'T THEN BE USED." IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE. 4/3/2023 - DURING EVALUATION OF THE RETURNED DEVICE, AN ATTEMPT TO ADVANCE THE SAFETY WAS UNSUCCESSFUL DUE TO THE BEND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16792062 ↗MalfunctionMar 28, 2023Defective Component; Defective Component
CUSTOMER REPORTED THAT THE CLAMP DOES NOT FULFILL ITS FUNCTION. IT IS POSSIBLE TO INJECT THE TREATMENT WITH THE CLAMP IN POSITION. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16632503 ↗MalfunctionNov 4, 2020Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THE NEEDLE WAS ATTACHED TO A PATIENT RECEIVING TREATMENT WHEN THE PATIENT NOTICED THAT HER SHOULDER WAS WET. ON CLOSE EXAMINATION, THE LINE HAS A VERY SMALL HOLE IN IT WHICH WAS CAUSING A LEAKAGE. FORTUNATELY THIS HAPPENED VERY EARLY ON RECEIVING TREATMENT, SO THE PATIENT MOST LIKELY WASN¿T EXPOSED TO THE AGENT BEING GIVEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10788111 ↗MalfunctionAug 8, 2019Fluid/Blood Leak
IT WAS REPORTED THAT THE PORT NEEDLE WAS INSERTED FOR THREE DAYS WHEN THE PATIENT TOLD THE NURSE THAT THERE WAS BLOOD IN THE TUBE. IT WAS STATED THAT THE EXTENSION TUBE WAS FULL OF BLOOD AND WAS DRIPPING. THE NEEDLE WAS REMOVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8875398 ↗
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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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