Port Access Needle 0652015Recalls & reported problems
Bard Access Systems, Inc. · PowerLoc 20G x 1.5 inch · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741047756), received between Mar 25, 2020 and Mar 25, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (2 reports).
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.
Most reported problems
Device problems
- Activation Problem2
Patient problems
- Exposure to Body Fluids2
- Needle Stick/Puncture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2020Activation Problem; Activation Problem
IT WAS REPORTED VIA MEDWATCH "POWERLOC USED FOR ACCESS TO PORT. THE "LOCK OUT" LEGS DID NOT ENGAGE ON RETRACTION LEAVING THE NEEDLE EXPOSED WHICH CAUSED A NEEDLE STICK TO PROVIDER. THE STICK CAME JUST AS THE NEEDLE WAS BEING PLACED IN SHARPS CONTAINER SO THE ACTUAL NEEDLE IS NOT AVAILABLE. WE IMMEDIATELY WENT TO THE SAME SUPPLY BIN AND TESTED ANOTHER ONE FROM WHAT WE BELIEVE IS THE EXACT SAME LOT AND THE DEFECT WAS DUPLICATED. WE PULLED THAT LOT AND HAVE A SAMPLE FROM THAT LOT AVAILABLE FOR ANALYSIS." THIS REPORT ADDRESSES THE SECOND OF TWO DEVICES.
Patient problems: Exposure to Body Fluids; Needle Stick/Puncture
MAUDE report 9878951 ↗MalfunctionMar 25, 2020Activation Problem; Activation Problem
IT WAS REPORTED VIA MEDWATCH "POWERLOC USED FOR ACCESS TO PORT. THE "LOCK OUT" LEGS DID NOT ENGAGE ON RETRACTION LEAVING THE NEEDLE EXPOSED WHICH CAUSED A NEEDLE STICK TO PROVIDER. THE STICK CAME JUST AS THE NEEDLE WAS BEING PLACED IN SHARPS CONTAINER SO THE ACTUAL NEEDLE IS NOT AVAILABLE. WE IMMEDIATELY WENT TO THE SAME SUPPLY BIN AND TESTED ANOTHER ONE FROM WHAT WE BELIEVE IS THE EXACT SAME LOT AND THE DEFECT WAS DUPLICATED. WE PULLED THAT LOT AND HAVE A SAMPLE FROM THAT LOT AVAILABLE FOR ANALYSIS." THIS REPORT ADDRESSES THE FIRST OF TWO DEVICES.
Patient problems: Exposure to Body Fluids; Needle Stick/Puncture
MAUDE report 9878943 ↗
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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
- 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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