Port Access Kit 2132010Recalls & reported problems
Bard Access Systems, Inc. · PowerLoc MAX 20G X 1" with Y-Site PAK · Class 2
All models of Port Access Kit (49)
Data updated Oct 16, 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 00801741044182), received between Apr 6, 2026 and Apr 6, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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
- Loss of or Failure to Bond1
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.
MalfunctionApr 6, 2026Loss of or Failure to Bond
IT WAS REPORTED ALL 50 OF THE KITS ARE BEING SENT WITH A DRESSING THAT NO LONGER ADHERES TO THE PATIENT. CUSTOMER SAID NURSES ARE ALL USING SKIN PREP LIKE THEY ALWAYS DO AND THEY WON'T STICK. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES ALL FIFTY KITS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24791157 ↗
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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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