Port Access AN162010Recalls & reported problems
Bard Access Systems, Inc. · AllPoints Port Access System SafeStep 20G x 1 inch · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741119682), received between Jun 7, 2025 and Jun 7, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
1 FDA recall record name this device's identifier.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Jun 19, 2020Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Z-2664-2020 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, WHILE ACCESSING THE PATIENT'S PORT, THE HUBER NEEDLE SET MALFUNCTIONED AS SOON AS I FLUSHED THE LINE. THE FLUSH STARTED TO LEAK FROM THE TOP PIECE (SAFETY LOCK) OF THE HUBER NEEDLE AND WILL NOT DRAW BLOOD BACK FROM THE PORT. DE-ACCESSED HER PORT RIGHT AWAY AND RE ACCESS WITH NEW NEEDLE. PATIENT WAS ABLE TO GET HER TREATMENT, AND NO OTHER COMPLAINTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22163038 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.