Sentrinex SXSPT01Recalls & reported problems
Bard Access Systems, Inc. · 3D Port Access Dressing · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741117039), received between Mar 5, 2021 and Jun 3, 2025 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body Reaction2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE SENTRINEX DRESSING LIFTING OFF THE PATIENTS' SKIN WHEN THE DRESSING WAS DUE TO BE CHANGED AT THE INDICATED 7-DAY MARK. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22133480 ↗MalfunctionJun 3, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT EMERGENCY DEPARTMENT NURSE SHARED THE SENTRINEX DRESSING IS NOT ADHERING TO THE PATIENTS' SKIN WELL. THEY NOTICED THE DRESSING LIFTING, COMPROMISING THE INSERTION SITE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22132940 ↗MalfunctionMay 15, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED SENTRINEX NOT ADHERING TO PATIENTS SKIN FOR LONGER THAN 12 HOURS. ISSUE WAS CUSTOMER NOT UTILIZING SKIN PREP OR NOT USING SKIN PREP PROPERLY AND REPLACING PORT DRESSING MORE OFTEN THAN EXPECTED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22031924 ↗InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED VIA MS&S "PATIENT/NURSE CALLER WITH BARD PORT USING SENTRINEX 3D PORT DRESSING FROM HOSPITAL (REF# SXSPT01, LOT# 204006) EXPERIENCED A LOCAL SKIN REACTION SHE STATES IS FROM THE SENTRINEX ADHESIVE RESULTING IN SEROUS FLUID AND SOME SKIN COMING OFF WHERE SHE HAS HAD TO STOP HER INFUSION THERAPY. PATIENT HAS WEEKLY INFUSIONS. PATIENT CALLED HER CANCER CENTER DOCTOR AND DERMATOLOGIST. PATIENT HAS BEEN USING SENTRINEX DRESSING FOR THREE YEARS WITHOUT AN ISSUE AND HAS HAD TWO RECENT SKIN ISSUES WHEN USING THE DRESSING. THE LOT NUMBER PROVIDED IS THE HOSPITAL'S PRODUCT STOCK GIVEN TO PATIENT. PATIENT ASKING IF THERE HAS BEEN AN ADHESIVE CHANGE. PATIENT ALSO ASKING FOR PORT DWELL TIME." MS&S INFORMED I AM NOT AWARE OF AN ADHESIVE CHANGE WITH SENTINEX. EXPLAINED PORT DOES NOT EXPIRE ONCE IMPLANTED AND DWELL TIME IS A CLINICAL/MEDICAL DECISION MADE BETWEEN PATIENT AND HEALTHCARE PROVIDER. THIS REPORT ADDRESSES THE SECOND SKIN ISSUE THE PATIENT EXPERIENCED.
Patient problems: Foreign Body Reaction
MAUDE report 11422484 ↗InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED VIA MS&S "PATIENT/NURSE CALLER WITH BARD PORT USING SENTRINEX 3D PORT DRESSING FROM HOSPITAL (REF# SXSPT01, LOT# 204006) EXPERIENCED A LOCAL SKIN REACTION SHE STATES IS FROM THE SENTRINEX ADHESIVE RESULTING IN SEROUS FLUID AND SOME SKIN COMING OFF WHERE SHE HAS HAD TO STOP HER INFUSION THERAPY. PATIENT HAS WEEKLY INFUSIONS. PATIENT CALLED HER CANCER CENTER DOCTOR AND DERMATOLOGIST. PATIENT HAS BEEN USING SENTRINEX DRESSING FOR THREE YEARS WITHOUT AN ISSUE AND HAS HAD TWO RECENT SKIN ISSUES WHEN USING THE DRESSING. THE LOT NUMBER PROVIDED IS THE HOSPITAL'S PRODUCT STOCK GIVEN TO PATIENT. PATIENT ASKING IF THERE HAS BEEN AN ADHESIVE CHANGE. PATIENT ALSO ASKING FOR PORT DWELL TIME." MS&S INFORMED I AM NOT AWARE OF AN ADHESIVE CHANGE WITH SENTINEX. EXPLAINED PORT DOES NOT EXPIRE ONCE IMPLANTED AND DWELL TIME IS A CLINICAL/MEDICAL DECISION MADE BETWEEN PATIENT AND HEALTHCARE PROVIDER. THIS REPORT ADDRESSES THE FIRST SKIN ISSUE THE PATIENT EXPERIENCED.
Patient problems: Foreign Body Reaction
MAUDE report 11422285 ↗
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- ALLEVYN LIFE L 15.4X15.4 CTN10 66801069Smith & Nephew Medical Limited · Dressing, Wound, Occlusive28 reports
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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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