Port Access Kit PA-0029YNRecalls & reported problems
Bard Access Systems, Inc. · Port Access Kit SafeStep 22G x 0.75 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741085499), received between Jun 4, 2020 and Aug 26, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).
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 Leak4
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED TWO BARD PORT ACCESS KITS WERE FOUND LEAKING AT THE CLAVE AND HAD TO RE-ACCESS A PATIENT. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10457517 ↗MalfunctionAug 26, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED TWO BARD PORT ACCESS KITS WERE FOUND LEAKING AT THE CLAVE AND HAD TO RE-ACCESS A PATIENT. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10457516 ↗MalfunctionJun 4, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED PORT NEEDLE DEVICE INTACT UPON PRE-FLUSHING, PATIENT PORT-A-CATH ACCESSED WITH DEVICE, ON ASPIRATION FOR BLOOD RETURN, NOTED BLOOD DROPS FORMING AT POINT WHERE TUBING CONNECTS TO PLASTIC CLEAR PORT NEEDLE DEVICE. EQUIPMENT FAILURE DUE TO HOLE/ IMPAIRMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10121448 ↗MalfunctionJun 4, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED PT ACCESSED WITH PORT NEEDLE. LINE FLUSHED AND THEN ASPIRATED AND THAT¿S WHEN BLOOD STARTED DRIPPING FROM WHERE THE LINE/ TUBE IS CONNECTED TO THE NEEDLE. ON (B)(6) 2020: THE IMPAIRMENT WAS AT THE EXACT POINT WHERE THE TUBING CONNECTS TO THE PLASTIC PORT NEEDLE DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10121440 ↗
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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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