Port Access Needle S02320-10Recalls & reported problems
Bard Access Systems, Inc. · MiniLoc 20G x 1 inch with y-site · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741048937), received between Mar 19, 2020 and May 8, 2024 — classified as 2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT BLOOD AND FLUID IS GETTING BACKED UP IN THE Y-SITE, NOT ABLE TO FLUSH OUT AND CAUSED SEVERAL PATIENTS TO GET BLOOD ON THEMSELVES. IT WAS REPORTED BY THE CUSTOMER THIS OCCURS EVERY DAY HOWEVER A SPECIFIC QUANTITY OF EVENTS OR ANY FURTHER DETAILS WERE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19270434 ↗MalfunctionMar 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHEN THEY PULL THE NEEDLES OUT OF THE PACKAGING, THE TUBING TOWARDS THE DISTAL END IS FALLING OFF WHERE THE Y-SITE TUBING ATTACHES. NO OTHER INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9856222 ↗
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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 13, 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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