Port Access Kit PA-0030YNRecalls & reported problems
Bard Access Systems, Inc. · Port Access Kit SafeStep 22G x 1 inch with y-site · Class 2
All models of Port Access Kit (49)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741085512), received between Apr 29, 2021 and Apr 29, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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
- Crack1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE NEEDLES ARE SEVERELY LEAKING AT THE WHITE CONNECTOR. IT WAS STATED THAT THERE WAS NOT HARM OR INJURY TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11745014 ↗MalfunctionApr 29, 2021Crack; Crack
IT WAS REPORTED THE NEEDLES HAVE FINE CRACKS BETWEEN THE WHITE AND CLEAR PART . IT WAS STATED THAT THERE WAS NOT HARM OR INJURY TO PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11745008 ↗
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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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