Port Access Needle SHN20-60Recalls & reported problems
Bard Access Systems, Inc. · EZ Huber 20G x 15 mm, · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741089671), received between Aug 9, 2018 and Apr 28, 2022 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 Leak6
- Crack1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, "CRACKED NEEDLE, LEAKAGE (AT JUNCTION BETWEEN THE NEEDLE AND THE PLASTIC)." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14247214 ↗MalfunctionMar 10, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT NEEDLE CRACKED AT THE LEVEL OF THE WINGS. IT WAS STATED THAT A LEAK OCCURRED DUE TO THE CRACK AT THE WINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13726729 ↗MalfunctionFeb 25, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED LEAKAGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13601412 ↗MalfunctionJan 27, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT ON WITHDRAWING BLOOD, LEAK DISCOVERED WHERE PORT TUBING MEETS HUB. NO HARM TO PATIENT OR STAFF. IT WAS STATED THE NEEDLE REMOVED AND REPLACED WITH A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13374009 ↗MalfunctionSep 10, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER VIA DISTRIBUTOR: "THE NEEDLE IS LEAKING AT THE END PIECE." ADDITIONAL INFORMATION RECEIVED AUG 25 2021: IT WAS REPORTED THE DEFECTIVE NEEDLE WAS FRESHLY PLACED WITHOUT THE DEFECT BEING DISCOVERED. THE LEAK WAS DISCOVERED DURING SUBSEQUENT RINSING WITH SALINE SOLUTION. CONSEQUENCES FOR THE PATIENT: A NEW PORT HAD TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12455763 ↗MalfunctionAug 9, 2018Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED BY THE USER, " PORT PUNCTURED SALINE SOLUTION (NACL) DRIPS NEAR THE HANDLE DURING INJECTION. AIR MAY BE SUCKED IN THROUGH THE SYRINGE. LEAKAGE IS NOT VISIBLE TO THE HUMAN EYE. IT MAY BE A RISK OF AIR EMBOLISM." NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7770708 ↗
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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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