Port Access Needle 0604180Recalls & reported problems
Bard Access Systems, Inc. · Winged Infusion Set 19G x 1 inch · Class 2
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741037573), received between Jan 31, 2020 and Jun 24, 2020 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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.
Most reported problems
Device problems
- Fluid/Blood Leak9
Patient problems
- No Consequences Or Impact To Patient9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT IT IS VERY DIFFICULT TO CONNECT THE NEEDLE WHICH LEADS TO LEAKAGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10192510 ↗MalfunctionApr 21, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED LEAKAGE OF CYTOSTATIC PREPARATIONS. IT WAS STATED, "NEEDLE LEAKING AT THE CONNECTION OR NEEDLE IS VERY DIFFICULT TO CONNECT. THE MATERIAL WE CONNECT WITH IS OF NO IMPORTANCE. THE PROBLEM OCCURS WITH THE SYRINGES, MICROCLAVE OR TROUSSES. THE PROBLEM IS REALLY AT THE CONNECTION POINT OF THE NEEDLES."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9984250 ↗MalfunctionJan 31, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A LEAKAGE OF CYTOSTAT PREPARATIONS IN VARIOUS PATIENTS. IT WAS STATED WHEN RECEIVING CHEMO A LEAKAGE WAS NOTED WITH 7 PATIENTS. SOME PATIENTS HAD TO COME IN FROM HOME. AT ALL 7 PATIENTS THE SAME LOT# WAS USED. THIS REPORT ADDRESSES THE SIXTH PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9655529 ↗MalfunctionJan 31, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A LEAKAGE OF CYTOSTAT PREPARATIONS IN VARIOUS PATIENTS. IT WAS STATED WHEN RECEIVING CHEMO A LEAKAGE WAS NOTED WITH 7 PATIENTS. SOME PATIENTS HAD TO COME IN FROM HOME. AT ALL 7 PATIENTS THE SAME LOT# WAS USED. THIS REPORT ADDRESSES THE FIFTH PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9655506 ↗MalfunctionJan 31, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A LEAKAGE OF CYTOSTAT PREPARATIONS IN VARIOUS PATIENTS. IT WAS STATED WHEN RECEIVING CHEMO A LEAKAGE WAS NOTED WITH 7 PATIENTS. SOME PATIENTS HAD TO COME IN FROM HOME. AT ALL 7 PATIENTS THE SAME LOT# WAS USED. THIS REPORT ADDRESSES THE SEVENTH PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9655479 ↗MalfunctionJan 31, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A LEAKAGE OF CYTOSTAT PREPARATIONS IN VARIOUS PATIENTS. IT WAS STATED WHEN RECEIVING CHEMO A LEAKAGE WAS NOTED WITH 7 PATIENTS. SOME PATIENTS HAD TO COME IN FROM HOME. AT ALL 7 PATIENTS THE SAME LOT# WAS USED. THIS REPORT ADDRESSES THE FOURTH PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9655078 ↗MalfunctionJan 31, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A LEAKAGE OF CYTOSTAT PREPARATIONS IN VARIOUS PATIENTS. IT WAS STATED WHEN RECEIVING CHEMO A LEAKAGE WAS NOTED WITH 7 PATIENTS. SOME PATIENTS HAD TO COME IN FROM HOME. AT ALL 7 PATIENTS THE SAME LOT# WAS USED. THIS REPORT ADDRESSES THE SECOND PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9655076 ↗MalfunctionJan 31, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A LEAKAGE OF CYTOSTAT PREPARATIONS IN VARIOUS PATIENTS. IT WAS STATED WHEN RECEIVING CHEMO A LEAKAGE WAS NOTED WITH 7 PATIENTS. SOME PATIENTS HAD TO COME IN FROM HOME. AT ALL 7 PATIENTS THE SAME LOT# WAS USED. THIS REPORT ADDRESSES THE THIRD PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9655075 ↗MalfunctionJan 31, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A LEAKAGE OF CYTOSTAT PREPARATIONS IN VARIOUS PATIENTS. IT WAS STATED WHEN RECEIVING CHEMO A LEAKAGE WAS NOTED WITH 7 PATIENTS. SOME PATIENTS HAD TO COME IN FROM HOME. AT ALL 7 PATIENTS THE SAME LOT# WAS USED. THIS REPORT ADDRESSES THE FIRST PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9655042 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.