Port Access Kit 2141975Recalls & reported problems
Bard Access Systems, Inc. · PowerLoc MAX 19G x .75" PAK · Class 2
All models of Port Access Kit (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741044267), received between Sep 11, 2024 and Sep 11, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
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-2662-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE APPEARED TO BE A HOLE RIGHT WHERE THE NEEDLE CONNECTS TO THE FLAT "PLATFORM" LOOKING PIECE THAT BEGAN TO LEAK WHEN HUBER WAS FLUSHED. ONE OF MY NURSES WAS ACCESSING A PORT ON (B)(6) AND ENDED UP HAVING TO REMOVE IT AND REPLACE IT RIGHT AWAY. WHEN HE ATTEMPTED TO ASPIRATE UPON ACCESSING, HE GOT AIR BACK AND WHEN HE ATTEMPTED TO FLUSH, IT LEAKED EVERYWHERE. HE SAID WHEN HE REMOVED IT, THERE APPEARED TO BE A HOLE RIGHT WHERE THE NEEDLE CONNECTS TO THE FLAT "PLATFORM" LOOKING PIECE. PATIENT REQUIRED A SECOND POKE TO ACCESS THEIR PORT DUE TO THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20195801 ↗
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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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