Port Access AN142010GRecalls & reported problems
Bard Access Systems, Inc. · AllPoints Port Access System PowerLoc Max 20G x 1 inch + GuardIVa · Class 2
All models of Port Access (11)
Data updated Oct 16, 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 00801741119323), received between Jun 4, 2018 and Nov 9, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination With Biological Material” (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 16, 2026.
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
- Device Contamination With Biological Material1
- Fluid/Blood Leak1
Patient problems
- Insufficient Information1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER "A TEGADERM DRESSING IS APPLIED TO THE PORT, BUT THE DISTAL END OF THE LINE WHERE IT MEETS THE CLAVE IS WHERE THE BREAK IS OCCURRING AND THIS PORTION HANGS DOWN BELOW THE DRESSING. OCCURRED IN PEDIATRIC DEPARTMENT."
Patient problems: Insufficient Information
MAUDE report 15763356 ↗MalfunctionJun 4, 2018Device Contamination With Biological Material
IT WAS REPORTED THAT THE NURSE OPENED UP A BRAND NEW ALLPOINTS PORT ACCESS KIT AND FOUND A HUMAN HAIR UNDERNEATH THE GUARDIVA PATCH. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7567527 ↗
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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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