AllPoints Port Access System PowerLoc Max AN132075BRecalls & reported problems
Bard Access Systems, Inc. · AllPoints Port Access System PowerLoc Max 20G x 0.75 inch with Y-Site + BioPatch · Class 2
Data updated Oct 18, 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 00801741215216), received between Nov 10, 2021 and Nov 15, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Crack1
- Fluid/Blood Leak1
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 15, 2021Crack; Crack
IT WAS REPORTED "CUSTOMER MENTIONED THAT THEY HAD EXPERIENCED CONTRAST LEAKING AT THE INSERTION SITE AND/OR AROUND NEEDLE. SHE MENTIONED THAT CT WAS THE AREA CATCHING THE ISSUE AND THEY MIGHT BE ABLE TO PROVIDE MORE DETAILS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12815080 ↗MalfunctionNov 10, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "CUSTOMER SAID THAT WHEN SHE WAS USING ONE OF THE POWERLOC MAX NEEDLES FROM THE NEW KITS THEY HAD AN ISSUE. SHE STATED THAT THERE WAS A HOLE IN THE TUBING COMING FROM THE Y-SITE THAT WAS LEAKING. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12790860 ↗
Other Non-coring (Huber) needle devices
- SafeStep CPA00049Bard Access Systems, Inc. · Non-Coring (Huber) Needle1 recall0 reports
- SafeStep CPA00040Bard Access Systems, Inc. · Non-Coring (Huber) Needle1 recall0 reports
- SafeStep CPA00042ABard Access Systems, Inc. · Non-Coring (Huber) Needle1 recall0 reports
- INTERA AP-07014USIntera Oncology Inc. · Non-Coring (Huber) Needle37 reports
- SURECAN SAFETY II 4447006-02B. Braun Medical Inc. · Non-Coring (Huber) Needle13 reports
- SURECAN SAFETY II 4447005-02B. Braun Medical Inc. · Non-Coring (Huber) Needle6 reports
- AllPoints Port Access System SafeStep AN152075MBard Access Systems, Inc. · Non-coring (Huber) needle5 reports
- SURECAN SAFETY II 4447012-02B. Braun Medical Inc. · Non-Coring (Huber) Needle4 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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