AllPoints Port Access System SafeStep AN152075MRecalls & reported problems
Bard Access Systems, Inc. · AllPoints Port Access System SafeStep 20G x 0.75 inch with Y-Site · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741232473), received between Sep 9, 2025 and Sep 9, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 reports).
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.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED SENTRINEX DRESSING IN APPAS LIFTED AND CAME OFF AND NEEDLE DISLODGED. CUSTOMER COMPLAINED THAT THERE WAS PERSPIRATION INSIDE THE DOME OF THE DRESSING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23012112 ↗MalfunctionSep 9, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED SENTRINEX DRESSING IN APPAS LIFTED AND CAME OFF AND NEEDLE DISLODGED. CUSTOMER COMPLAINED THAT THERE WAS PERSPIRATION INSIDE THE DOME OF THE DRESSING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23012111 ↗MalfunctionSep 9, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED SENTRINEX DRESSING IN APPAS LIFTED AND CAME OFF AND NEEDLE DISLODGED. CUSTOMER COMPLAINED THAT THERE WAS PERSPIRATION INSIDE THE DOME OF THE DRESSING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23012109 ↗MalfunctionSep 9, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED SENTRINEX DRESSING IN APPAS LIFTED AND CAME OFF AND NEEDLE DISLODGED. CUSTOMER COMPLAINED THAT THERE WAS PERSPIRATION INSIDE THE DOME OF THE DRESSING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23012105 ↗MalfunctionSep 9, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED SENTRINEX DRESSING IN APPAS LIFTED AND CAME OFF AND NEEDLE DISLODGED. CUSTOMER COMPLAINED THAT THERE WAS PERSPIRATION INSIDE THE DOME OF THE DRESSING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23012035 ↗
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
- SURECAN SAFETY II 4447012-02B. Braun Medical Inc. · Non-Coring (Huber) Needle4 reports
- MEDLINE HNX20075Medline Industries, 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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