PowerLoc 8652010Recalls & reported problems
Bard Access Systems, Inc. · BD PowerLoc™ Safety Infusion Set · Class 2
All models of PowerLoc (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741048319), received between Jul 1, 2025 and Sep 30, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported a single use implantable drug delivery device with a port needle was connected for a patient on September 8. On September 10, during the infusion, fluid leakage was discovered at the connection between the port needle and the tubing, so a new port needle was used for the puncture. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941954 ↗MalfunctionMay 5, 2026Fluid/Blood Leak
IT WAS REPORTED ON (B)(6) 2026 THE CLINICIAN PLACED THE CANNULA, AND WHEN THE INFUSION PORT WAS INSERTED TO SEAL THE TUBING, IT WAS FOUND TO BE LEAKING AT THE YELLOW BUTTERFLY PLANE WING OF THE INFUSION PORT NEEDLE, BUT THE PHENOMENON WAS NOT FOUND WHEN THE INFUSION PORT NEEDLE WAS IN THE PRE-FLUSH TUBING. IMMEDIATELY REPLACED THE NEW IMPLANTED PORT CANNULA, THE NEW IMPLANTED PORT NEEDLE FOR THE SAME COMPANY DIFFERENT MODELS OF PRODUCTS. BECAUSE THE PATIENT'S IMPLANTED PORT IS DEEPER, THE INFUSION PORT NEEDLE USED AT THE BEGINNING WAS LONGER, AND IT WAS FOUND THAT THE LONG NEEDLE WAS INSERTED WITH A LONG CUT AND THE LONG NEEDLE HAD LEAKAGE, AND THEN IT WAS REPLACED WITH A SHORT NEEDLE, AND IT WAS FOUND THAT IT WAS ALSO OK. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25087485 ↗MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED TWO DEVICES HAD LEAKAGE DURING INFUSION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES BOTH DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23285844 ↗MalfunctionJul 1, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THE NEEDLES APPEAR TO BE INTACT AND THERE IS NO OBVIOUS FAULT. HOWEVER, WHEN FLUSHING THEY ARE LEAKING FROM BEHIND THE NEEDLE. IT APPEARS THE FAULT IS BETWEEN THE YELLOW GRIPPER AND THE NEEDLE. THERE WAS NO HARM OR MEDICAL INTERVENTION REQUIRED, ONCE FAULT WAS IDENTIFIED BEFORE BEING USED AND ANOTHER HUBER NEEDLE WAS USED IMMEDIATELY. IT WAS REPORTED THIS OCCURRED WITH SIX DEVICES. THIS REPORT ADDRESSES ALL SIX DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22370920 ↗
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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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