Port Access AN132075Recalls & reported problems
Bard Access Systems, Inc. · AllPoints Port Access System PowerLoc Max 20G x 0.75 inch with Y-Site · Class 2
All models of Port Access (11)
Data updated Oct 16, 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 00801741118968), received between Mar 2, 2023 and Mar 13, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Crack” (3 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-2660-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Crack3
- Fluid/Blood Leak1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2026Fluid/Blood Leak
IT WAS REPORTED VIA MEDSUN, PATIENT ARRIVED FOR SCHEDULED PARACENTESIS. PORTACATH ACCESSED PER PROTOCOL. GOOD BLOOD RETURN NOTED. FLUSH EASILY. ORDERED ALBUMIN WAS CONNECTED TO PORTACATH TUBING. ONCE ALBUMIN STARTED, IT WAS NOTED THAT IT WAS LEAKING FROM THE TUBING. ALL ACCESS SITES WERE CHECKED AND TIGHTENED. RE-FLUSHED TUBING. TUBING CONTINUED TO LEAK ON PATIENT'S SHIRT. A SECOND NURSE CONFIRMED LEAKING FROM THE TUBING. PORTACATH WAS RE-ACCESSED. ALBUMIN ADMINISTERED AS ORDERED. RN SUPERVISOR NOTIFIED. IR PA [INTERVENTIONAL RADIOLOGY PHYSICIAN ASSISTANT] NOTIFIED, NO FURTHER ORDERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24594037 ↗MalfunctionMar 2, 2023Crack; Crack
IT WAS REPORTED, PICC NURSES HAD PORT-NEEDLES THAT NEEDED REPLACEMENT DUE TO LEAKING, IT APPEARS HUBS WERE CRACKED. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: Insufficient Information
MAUDE report 16475510 ↗MalfunctionMar 2, 2023Crack; Crack
IT WAS REPORTED, PICC NURSE HAD PORT-NEEDLE THAT NEEDED REPLACEMENT DUE TO LEAKING, IT APPEARS HUB WAS CRACKED.
Patient problems: Insufficient Information
MAUDE report 16475502 ↗MalfunctionMar 2, 2023Crack; Crack
IT WAS REPORTED, PICC NURSES HAD PORT-NEEDLES THAT NEEDED REPLACEMENT DUE TO LEAKING, IT APPEARS HUBS WERE CRACKED. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: Insufficient Information
MAUDE report 16475495 ↗
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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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