Port Access Needle 2206219Recalls & reported problems
Bard Access Systems, Inc. · Winged Infusion Set 19G x 1 inch with y-site · Class 2
- 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 00801741065880), received between Mar 12, 2020 and Mar 12, 2020 — classified as 4 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak4
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 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT LEAKAGE AT THE NEEDLE TUBING. IT WAS STATED THIS HAPPENED WITH THREE NEEDLES USED ON THREE SEPARATE PATIENTS. ACTIONS TAKEN IMMEDIATELY: STOPPING THE INFUSIONS AND CHECKING THE CHAMBER WITH DIFFICULTY BECAUSE DEVICE ALMOST CLOSED. THIS REPORT ADDRESSES THE SECOND OF THREE PATIENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9826391 ↗MalfunctionMar 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT LEAKAGE AT THE NEEDLE TUBING. IT WAS STATED THIS HAPPENED WITH THREE NEEDLES USED ON THREE SEPARATE PATIENTS. ACTIONS TAKEN IMMEDIATELY: STOPPING THE INFUSIONS AND CHECKING THE CHAMBER WITH DIFFICULTY BECAUSE DEVICE ALMOST CLOSED. THIS REPORT ADDRESSES THE THIRD OF THREE PATIENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9826389 ↗MalfunctionMar 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE HAS BEEN LEAKAGE AT THE NEEDLE TUBING WITH MULTIPLE DEVICES. IT IS UNKNOWN THE NUMBER OF DEVICES AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9826388 ↗MalfunctionMar 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT LEAKAGE AT THE NEEDLE TUBING. IT WAS STATED THIS HAPPENED WITH THREE NEEDLES USED ON THREE SEPARATE PATIENTS. ACTIONS TAKEN IMMEDIATELY: STOPPING THE INFUSIONS AND CHECKING THE CHAMBER WITH DIFFICULTY BECAUSE DEVICE ALMOST CLOSED. THIS REPORT ADDRESSES THE FIRST OF THREE PATIENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9826348 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.