Port Access Needle SHW20-75YSRecalls & 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
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741089879), received between Jun 28, 2019 and May 21, 2022 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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 Leak11
- Leak/Splash8
- Device Dislodged or Dislocated1
Patient problems
- No Consequences Or Impact To Patient11
- No Known Impact Or Consequence To Patient7
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "Y PORT IS NOT SEALED PROPERLY, LEADING TO BLOOD LEAKAGE. NO ADVERSE EVENTS AND NO DATES OF OCCURRENCE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14465367 ↗MalfunctionMar 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED HUBER NEEDLE MIGRATING OUT OF THE PORT WHEN THEY SEND PATIENTS HOME. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11426150 ↗MalfunctionFeb 11, 2021Fluid/Blood Leak
IT WAS REPORTED "CUSTOMER CALLED IN STATING THEY HAVE LEAK FROM THE CLAVE (WHITE SIDE) USED FOR CHEMO PATIENTS. THE LEAK OCCURRED DURING THE FLUSH." ADDITIONAL INFO. RECEIVED 02/04/2021: "WHAT THEY¿RE BEING TREATED FOR: METASTATIC POORLY -DIFFERENTIATED ADENOCARCINOMA OF THE LUNG WITH METASTATIC DISEASE TO BONE, 'NO PATIENT HARM REPORTED" IT WAS STATED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11313531 ↗MalfunctionFeb 11, 2021Fluid/Blood Leak
IT WAS REPORTED "CUSTOMER CALLED IN STATING THEY HAVE LEAK FROM THE CLAVE (WHITE SIDE) USED FOR CHEMO PATIENTS. THE LEAK OCCURRED DURING THE FLUSH." ADDITIONAL INFO. RECEIVED 02/04/2021: "WHAT THEY¿RE BEING TREATED FOR: METASTATIC POORLY -DIFFERENTIATED ADENOCARCINOMA OF THE LUNG WITH METASTATIC DISEASE TO BONE, 'NO PATIENT HARM REPORTED" IT WAS STATED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11313527 ↗MalfunctionNov 20, 2020Leak/Splash
IT WAS REPORTED THAT WHILE TRAILING THE HUBER NEEDLES, THE CLINICIANS HAD A FEW LEAKS AT THE Y-SITE HUB AS THEY WERE FLUSHING AT THE END CONNECTION. THE BLUE HUB POPS OUT A LITTLE AND IT LEAKS. THE FACILITY SAID THEY ARE UNSURE IF IT IS DUE TO PRESSURE OR ANOTHER FACTOR BUT STATED THEIR CONCERN FOR PATIENT AND STAFF SAFETY IF IT WERE TO HAPPEN WITH CHEMO INSTEAD OF JUST SALINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10880601 ↗MalfunctionNov 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE EZ HUBER SAFETY INFUSION SET LEAKED AT THE BLUE Y-SITE VALVE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9267034 ↗MalfunctionSep 25, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE NEEDLES ARE LEAKING BLOOD AT Y-PORT AFTER FLUSH. THE FACILITY REPORTED THREE DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9121055 ↗MalfunctionSep 25, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE NEEDLES ARE LEAKING BLOOD AT Y-PORT AFTER FLUSH. THE FACILITY REPORTED THREE DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9121049 ↗MalfunctionSep 25, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE NEEDLES ARE LEAKING BLOOD AT Y-PORT AFTER FLUSH. THE FACILITY REPORTED THREE DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9120985 ↗MalfunctionAug 30, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak
IT WAS REPORTED THAT THE HUBER NEEDLE LEAKED AT THE PORT. NO OTHER INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8952357 ↗MalfunctionAug 30, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak
IT WAS REPORTED THAT THE HUBER NEEDLE LEAKED AT THE PORT. NO OTHER INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8952354 ↗MalfunctionAug 30, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak
IT WAS REPORTED THAT THE HUBER NEEDLE LEAKED AT THE PORT. NO OTHER INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8952349 ↗MalfunctionAug 30, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak
IT WAS REPORTED THAT THE HUBER NEEDLE LEAKED AT THE PORT. NO OTHER INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8952348 ↗MalfunctionAug 8, 2019Leak/Splash
IT WAS REPORTED THAT AFTER ACCESSING THE PORT, LEAKAGE WAS NOTED FROM THE NEEDLE DURING INFUSION. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8874886 ↗MalfunctionJun 28, 2019Leak/Splash
IT WAS REPORTED THAT THE NEEDLE WAS LEAKING AT THE PORT HUB AND TUBING LEG CONNECTION WITH FIRST USE/ACCESS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8745969 ↗MalfunctionJun 28, 2019Leak/Splash
IT WAS REPORTED THAT THE NEEDLE WAS LEAKING AT THE PORT HUB AND TUBING LEG CONNECTION WITH FIRST USE/ACCESS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8745681 ↗
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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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