PowerLoc CPA00029Recalls & reported problems
Bard Access Systems, Inc. · Port Access Kit · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741129735), received between Jun 22, 2023 and Nov 22, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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
- Crack1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED BY CUSTOMER THAT NEEDLES SELF-RETRACTING DURING PRESSURE INFUSION. NO OTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18195628 ↗MalfunctionJun 22, 2023Crack; Crack
IT WAS REPORTED BY THE CUSTOMER THAT THE LUER CONNECTOR IS CRACKING. IT HAS THOUGHT TO BE BECAUSE WE ARE SCREWING THE CARESITE LEUR ACCESS DEVICE ONTO THE TUBING TOO HARD. THE MAJORITY OF THE TIME CUSTOMER USE THE POWER LOC MAX 20GX1IN NEEDLE SO I¿M UNSURE IF THE HUBER NEEDLE/TUBING IS HAVING THE SAME ISSUE. CUSTOMER IS THINKING THEY ARE STILL USING TOO MUCH FORCE WHEN PUTTING THE CARESEITE DEVICE ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17186525 ↗
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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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