Port Access AN162075Recalls & reported problems
Bard Access Systems, Inc. · AllPoints Port Access System SafeStep 20G x 0.75 inch · Class 2
All models of Port Access (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741119675), received between May 21, 2022 and May 1, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (2 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 16, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Activation Problem2
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2026Activation Problem
IT WAS REPORTED BY THE CUSTOMER THAT SAFESTEP 20G X 0.75IN HUBER NEEDLE WOULD NOT ENGAGE THE SAFETY MECHANISM. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25057268 ↗MalfunctionMay 1, 2026Activation Problem
IT WAS REPORTED BY THE CUSTOMER THAT SAFESTEP 20G X 0.75IN HUBER NEEDLE WOULD NOT ENGAGE THE SAFETY MECHANISM. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056829 ↗MalfunctionMay 21, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "FOUND A PORT NEEDLE THAT LOOKS LIKE THE PLASTIC HOUSING IS CRACKED. IT WAS LEAKING BOTH BLOOD AND FLUIDS UPON FLUSHING AND ASPIRATION." ADD INFO RCVD 05/11/2022: WAS THE PRODUCT USED ON A PATIENT? YES. WAS THERE ANY PATIENT HARM REPORTED? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14465991 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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