Port Access Needle 585112Recalls & reported problems
Bard Access Systems, Inc. · Sfty Huber 20Ga x .75in · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741044922), received between Nov 21, 2017 and Mar 5, 2021 — classified as 10 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 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak6
- Leak/Splash2
- Air Leak1
- Partial Blockage1
Patient problems
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED IN (B)(6) 2020 THERE WAS AN ISSUE WITH A 0.75" NEEDLE THAT HAD BEEN EXTERNALLY LEAKING WITH AIR BUBBLES NOTED IN LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11426089 ↗MalfunctionJun 10, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "THE NURSE WAS DRAWING BLOOD FOR LABS AND NOTED AIR BUBBLES IN TUBING, WHEN FLUSHED IT THEN LEAKED AT THE CONNECTION BETWEEN THE NEEDLE AND TUBING."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10139466 ↗MalfunctionJun 10, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "NOTED LEAKING AT THE CONNECTION BETWEEN NEEDLE AND TUBING WHEN FLUSHING THE LINE ON PATIENT."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10139464 ↗MalfunctionOct 23, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE SAFETY HUBER NEEDLE LEAKED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9225336 ↗MalfunctionOct 23, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE SAFETY HUBER NEEDLE LEAKED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9225329 ↗MalfunctionOct 23, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE SAFETY HUBER NEEDLE LEAKED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9225028 ↗MalfunctionJun 29, 2018Leak/Splash
IT WAS REPORTED THAT THE FACILITY HAS HAD ISSUES WITH THE SAFETY HUBER NEEDLE LEAKING AT THE WHITE HUB/BLUE VALVE. NO OTHER DETAILS WERE PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7653329 ↗MalfunctionJun 14, 2018Leak/Splash
FACILITY HAS RAN ACROSS ISSUES WITH THE SAFETY HUBER NEEDLE. THIS FILE IS FOR THE WHITE CONNECTOR LEAKAGE. NO OTHER DETAILS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7604008 ↗MalfunctionMay 23, 2018Partial Blockage
IT WAS REPORTED THAT PORT WAS ACCESSED WITHOUT DIFFICULTY, BUT BLOOD BACKED UP THE LENGTH OF THE TUBING. IT WAS STATED PATIENT WAS RECEIVING IV FLUSH INFUSION AT THE TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7539200 ↗MalfunctionNov 21, 2017Air Leak
UPON ACCESSING THE POWERPORT, AIR NOTED WHILE ATTEMPTING TO ASPIRATE BLOOD FOR LAB TESTS. LOTS OF BUBBLES MIXED WITH BLOOD OBTAINED. ATTEMPTED TO OBTAIN BLOOD FROM OTHER HUB SITE MET WITH SAME RESULT. NEEDLE IMMEDIATELY REMOVED AND NEW NEEDLE INSERTED. BLOOD OBTAINED WITH NO AIR NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7049141 ↗
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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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