Port Access Kit 2682010Recalls & reported problems
Bard Access Systems, Inc. · Port Access Kit MiniLoc 20G x 1 inch with y-site · Class 2
All models of Port Access Kit (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741044632), received between Dec 30, 2022 and Jul 9, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak6
- Detachment of Device or Device Component1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Chemical Exposure1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT WHEN THEY ACCESS THE PORTS WITH THE HUBER NEEDLE AND THEY WERE FLUSHING/ASPIRATING BLOOD BACK. THEY NOTICED A LITTLE DROP/BEAD OF SALINE MIXED WITH BLOOD AT THE VERY TOP OF THE WIND SET WHERE IT BENDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22460215 ↗MalfunctionJul 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT WHEN THEY ACCESS THE PORTS WITH THE HUBER NEEDLE AND THEY WERE FLUSHING/ASPIRATING BLOOD BACK. THEY NOTICED A LITTLE DROP/ BEAD OF SALINE MIXED WITH BLOOD AT THE VERY TOP OF THE WIND SET WHERE IT BENDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22458547 ↗MalfunctionJun 30, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED BY THE CUSTOMER THAT THE Y-SITE CAP IS EITHER LOOSE OR COMING OFF CREATING EXPOSURE RISKS FOR BOTH THE NURSE AND PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17240928 ↗MalfunctionDec 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
(B) IT WAS REPORTED BY THE CUSTOMER ¿NURSE REPORTS MINILOC PORT ACCESS NEEDLE WHERE THE HARD PLASTIC AROUND THE HUB AND TUBING WAS CRACKING AND LEAKED CHEMOTHERAPY SOLUTION (FLUOROURACIL) ONTO THE PATIENT."
Patient problems: Chemical Exposure
MAUDE report 16078356 ↗MalfunctionDec 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER ¿NURSE REPORTS THREE MINILOC PORT ACCESS NEEDLES WHERE THE HARD PLASTIC AROUND THE HUB AND TUBING WERE CRACKING AND LEAKED." THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16078275 ↗MalfunctionDec 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER ¿NURSE REPORTS THREE MINILOC PORT ACCESS NEEDLES WHERE THE HARD PLASTIC AROUND THE HUB AND TUBING WERE CRACKING AND LEAKED." THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16078272 ↗MalfunctionDec 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER ¿NURSE REPORTS THREE MINILOC PORT ACCESS NEEDLES WHERE THE HARD PLASTIC AROUND THE HUB AND TUBING WERE CRACKING AND LEAKED." THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16078268 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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