PowerLoc CPA00052Recalls & reported problems
Bard Access Systems, Inc. · Port Access Kit · Class 2
All models of PowerLoc (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741182150), received between Jan 13, 2023 and Apr 20, 2023 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak8
- Crack3
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Emotional Changes3
- Insufficient Information2
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT "ISSUE WITH THE HUBER NEEDLE LEAKING WHEN FLUSHED AT THE C SHAPED PIECE THAT IS USED TO REMOVE THE NEEDLE. THE NEEDLE HAS TO BE REMOVED AND THE PATIENT RE ACCESSED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777884 ↗MalfunctionApr 7, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER WHEN THEY WERE PRIMING THE LINE THEY NOTICED PRODUCT LEAKING AT JUNCTION BETWEEN TUBING AND NEEDLE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Emotional Changes; No Clinical Signs, Symptoms or Conditions
MAUDE report 16702581 ↗MalfunctionApr 3, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER, "THE HUBER NEEDLE IS LEAKING WHEN FLUSHED AT THE C SHAPED PIECE THAT IS USED TO REMOVE THE NEEDLE. THE NEEDLE HAS TO BE REMOVED AND THE PATIENT RE-ACCESSED." IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: Emotional Changes; No Clinical Signs, Symptoms or Conditions
MAUDE report 16668283 ↗MalfunctionApr 3, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER, THE HUBER NEEDLE IS LEAKING WHEN FLUSHED AT THE C SHAPED PIECE THAT IS USED TO REMOVE THE NEEDLE. THE NEEDLE HAS TO BE REMOVED AND THE PATIENT RE ACCESSED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: Emotional Changes; No Clinical Signs, Symptoms or Conditions
MAUDE report 16668271 ↗MalfunctionFeb 14, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT "I HAVE HAD TWO MORE LEAKING HUBERS IN THE SAME PLACE THIS WEEK." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: Insufficient Information
MAUDE report 16371771 ↗MalfunctionFeb 14, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT "I HAVE HAD TWO MORE LEAKING HUBERS IN THE SAME PLACE THIS WEEK." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: Insufficient Information
MAUDE report 16371768 ↗MalfunctionJan 26, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER "WE HAVE HAD 3 POWERLOC MAX WHERE THERE IS LEAKING FROM THE SAFETY MECHANISM ON TOP (THE PIECE YOU PULL WHEN REMOVING THE NEEDLE) WITH FLUSHING ONCE THE PORT IS ACCESSED." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16251038 ↗MalfunctionJan 26, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER "WE HAVE HAD 3 POWERLOC MAX WHERE THERE IS LEAKING FROM THE SAFETY MECHANISM ON TOP (THE PIECE YOU PULL WHEN REMOVING THE NEEDLE) WITH FLUSHING ONCE THE PORT IS ACCESSED." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16251000 ↗MalfunctionJan 13, 2023Crack; Crack
IT WAS REPORTED LEAKING PORT ACCESS NEEDLE, THE NEEDLE WAS INSERTED AND WHEN FLUSHED IT LEAKED FROM THE CLEAR 'U' SHAPED PIECE. THE PATIENT HAD TO BE RE-STUCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16157989 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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