PowerLoc 8651934Recalls & reported problems
Bard Access Systems, Inc. · BD PowerLoc™ Safety Infusion Set · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741048302), received between May 12, 2025 and May 12, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
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.
MalfunctionMay 12, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED BY THE CUSTOMER "TRANSFUSED A PATIENT'S TREATMENT WITHOUT ISSUE HOWEVER ON DISCONNECTING AND FLUSHING THE LINE IT BLOCKED. MYSELF AND TWO OTHER NURSES ASSESSED THE PATIENT AND THE NEEDLE, ULTIMATELY REMOVING IT. WE TRIED TO FLUSH IT WHEN IT WAS OUT OF THE PATIENT AND IT REALLY WOULDN'T LET US, IT WAS TOTALLY BLOCKED. WE RE-ACCESSED THE PATIENT WITH A NEW NEEDLE AND FLUSHED THE PORT WITHOUT ISSUE, PROVIDING IT WAS NOT THE PORT THAT WAS A PROBLEM." (B)(6) 2025 - DURING EVALUATION, A SMALL GREY MATERIAL WAS FOUND WITHIN THE TUBING OF THE INFUSION SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22007053 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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