PowerLoc 8652234Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741048364), received between Aug 5, 2020 and Jul 9, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (1 report).
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
- Activation Problem1
- Break1
- Contamination /Decontamination Problem1
- Detachment of Device or Device Component1
- Failure to Fire1
- Failure to Infuse1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Discomfort1
- Insufficient Information1
- No Patient Involvement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2026Product Quality Problem
Patient problems: Discomfort
MAUDE report 25764163 ↗MalfunctionNov 25, 2025Activation Problem; Activation Problem
IT WAS REPORTED THAT WHEN THE NURSE WAS MAINTAINING THE PATIENT'S INFUSION PORT, THE WHITE CLIP DETACHED DIRECTLY AND COVERED THE NEEDLE TIP UPON REMOVING THE CAP FROM THE SINGLE-USE IMPLANTABLE DRUG DELIVERY DEVICE (INDWELLING NEEDLE), RENDERING THE INDWELLING NEEDLE UNUSABLE. NO FURTHER DETAILS AVAILABLE OR PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23647865 ↗InjuryMay 15, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2025, WHEN MEDICAL STAFF USED A DISPOSABLE IMPLANTABLE DRUG DELIVERY CANNULA TO ADMINISTER INFUSION THERAPY TO A PATIENT, THE NEEDLE MALFUNCTIONED AND THE PUNCTURE FAILED. THEY IMMEDIATELY REPLACED THE NEEDLE WITH A NEW ONE AND PERFORMED A SECOND PUNCTURE, CAUSING SERIOUS INJURY TO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 22032449 ↗MalfunctionFeb 6, 2025Break; Break
IT WAS REPORTED BY THE CUSTOMER, AFTER THE CUSTOMER REMOVED THE HARBOR PIN FROM THE PACKAGE, HE FOUND THAT THE EXTENSION TUBING WAS SEPARATED FROM THE INTERFACE PART. CANNOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21327487 ↗MalfunctionNov 20, 2024Failure to Infuse; Detachment of Device or Device Component; Failure to Infuse; Detachment of Device or Device Component
IT WAS REPORTED, WHEN UNPACKING THE IMPLANTED PORT NEEDLES, ONE CASE COULD NOT BE PRIMED WITH FLUID. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20734027 ↗MalfunctionAug 5, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AFTER OPENING THE PACKAGE OF THE INDWELLING NEEDLE, IT IS FOUND THAT THERE IS FOREIGN MATTER AT THE PIPE JOINT.
Patient problems: No Patient Involvement
MAUDE report 10368592 ↗
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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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