Port Access Kit 2682034Recalls & reported problems
Bard Access Systems, Inc. · Port Access Kit MiniLoc 20G x 0.75 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
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741044656), received between Mar 5, 2020 and Apr 17, 2024 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak4
- Activation Problem3
- Crack2
- Detachment of Device or Device Component1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient6
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2024Activation Problem; Activation Problem
IT WAS REPORTED BY CUSTOMER THAT THERE WAS AN INCIDENT WHERE THE SAFETY MECHANISM DID NOT FUNCTION PROPERLY, POTENTIALLY EXPOSING THE PATIENT AND NURSE TO A NEEDLE STICK. THERE WAS NO PATIENT OR HEALTHCARE PROFESSIONAL IMPACT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19129688 ↗MalfunctionJun 27, 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 17213072 ↗MalfunctionDec 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER ¿NURSE REPORTS TWO MINILOC PORT ACCESS NEEDLES WHERE THE HARD PLASTIC AROUND THE HUB AND TUBING WERE CRACKING AND LEAKED." THIS REPORT ADDRESSES THE SECOND INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16078274 ↗MalfunctionDec 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER ¿NURSE REPORTS TWO MINILOC PORT ACCESS NEEDLES WHERE THE HARD PLASTIC AROUND THE HUB AND TUBING WERE CRACKING AND LEAKED." THIS REPORT ADDRESSES THE FIRST INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16078266 ↗MalfunctionJun 11, 2020Activation Problem; Activation Problem
IT WAS REPORTED THAT THE NEEDLE WOULD NOT ADVANCE PAST HALF WAY, THE SAFETY MECHANISM WOULD NOT ENGAGE. NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10142853 ↗MalfunctionJun 4, 2020Activation Problem; Activation Problem
IT WAS REPORTED "I WAS NOTIFIED BY PEDIATRICS ABOUT AN ISSUE THAT HAS OCCURRED WITH THE NEEDLE IN THE MINILOC PORT ACCESS KIT LOT # REDY3541 20 GA .75¿.RN INDICATED THAT THE NEEDLE WOULD NOT ADVANCE PAST HALF WAY. NO PATIENT HARM".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10121443 ↗MalfunctionMar 26, 2020Crack; Crack
IT WAS REPORTED THE INFUSION SET CRACKED AND LEAKED INFUSION FLUIDS. ON (B)(6) 2020- ADDITIONAL INFORMATION STATED, "THE ISSUE IS THAT THE MINILOC SAFETY INFUSION SET CRACKS AND LEAKS CHEMOTHERAPY DRUGS, APPROXIMATELY 24+ HOURS AFTER BEING USED WITH A PUMP. THE CRACK OCCURS ON THE ACCESS PORT CLOSEST TO THE PATIENT ( THE ONE WITHOUT WINGS) WHEN A LEUR ACCESS DEVICE IS PLACED. THAT IS WHAT CAUSES THE CRACK TO OCCUR. THE CRACK IS USUALLY NOT SEEN OR NOTICED INITIALLY BUT OVER TIME (APPROXIMATELY 24 HOURS LATER) WILL LEAK CHEMOTHERAPY."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9884831 ↗MalfunctionMar 12, 2020Crack; Crack
IT WAS REPORTED PATIENT RETURNED TO CANCER INFUSION CENTER WITH LEAKING MINILOC. NO OTHER INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9824958 ↗MalfunctionMar 5, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "THE MINILOC SAFETY INFUSION SET CRACKS AND LEAKS CHEMOTHERAPY DRUGS, APPROXIMATELY 24+ HOURS AFTER BEING USED WITH A PUMP."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9793864 ↗MalfunctionMar 5, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE MINILOC SAFETY INFUSION SET CRACKS AND LEAKS CHEMOTHERAPY DRUGS, APPROXIMATELY 24+ HOURS AFTER BEING USED WITH A PUMP. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9793857 ↗
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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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