AllPoints APDCSNG1Recalls & reported problems
Bard Access Systems, Inc. · AllPoints Dressing Change System for CVC · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741137587), received between Feb 28, 2020 and Mar 5, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 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.
Most reported problems
Device problems
- Loss of or Failure to Bond4
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE ICU HAS BEEN EXPERIENCING ADHESION ISSUE WITH THE DRESSING. IT WAS STATED, ¿THE CL DRESSING ISSUE HAS BEEN IDENTIFIED WITH OUR CLABSI WORK. THE LOCATION OF THE CL IN THE NECK IS BELIEVED TO BE THE MAJOR DRIVER FOR THE ISSUE.¿
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9793402 ↗MalfunctionMar 5, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THE ICU HAS BEEN EXPERIENCING ADHESION ISSUE WITH THE DRESSING. IT WAS STATED, ¿UPON AUDITING THE DRESSINGS ON THE ICU WE HAVE NOTICED A HIGHER RATE OF NON OCCLUSIVE DRESSINGS SINCE USING THIS STYLE OF DRESSING.¿
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9793401 ↗MalfunctionFeb 28, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED " HEALTH PROFESSIONAL REPORTED ADHESIVE ISSUE WITH DRESSING IN CENTRAL LINE TRAYS. DRESSING WAS "NON-OCCLUSIVE" "2 TIMES IN LAST 24 HOURS". AND THAT IT WAS "TOUGH TO STICK TO INSERTION SITE". THIS REPORT ADDRESSES THE SECOND TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9768864 ↗MalfunctionFeb 28, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED " HEALTH PROFESSIONAL REPORTED ADHESIVE ISSUE WITH DRESSING IN CENTRAL LINE TRAYS. DRESSING WAS "NON-OCCLUSIVE" "2 TIMES IN LAST 24 HOURS". AND THAT IT WAS "TOUGH TO STICK TO INSERTION SITE". THIS REPORT ADDRESSES THE FIRST TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9768700 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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