Port Access Kit PA-0032Recalls & reported problems
Bard Access Systems, Inc. · Port Access Kit SafeStep 20G x 1 inch · Class 2
All models of Port Access Kit (49)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00801741085543), received between Mar 17, 2023 and Mar 17, 2023 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jun 19, 2020Class IITerminated
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-2666-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- Anxiety1
- 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.
MalfunctionMar 17, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT WHEN ACCESSING THE PORT AND DRAWING BACK BLOOD UPON ACCESS AND THEN PULSATILE FLUSH BACK AND GET SALINE MIXED WITH THE BLOOD COMING FROM THE HUB, LEAKED FORCEFULLY, AND IT CAME OUT FORCEFULLY AND HIT THE PATIENT IN THE NECK. IT WAS STATED THERE WAS NO INJURY BUT THE DEVICE LEAKED ON THE PATIENT AND THE NURSE.
Patient problems: Anxiety; No Clinical Signs, Symptoms or Conditions
MAUDE report 16565293 ↗
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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 · each recall links to the FDA recall notice
- 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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