Port Access Needle 0604200Recalls & reported problems
Bard Access Systems, Inc. · Winged Infusion Set 20G x 1 inch · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741065811), received between May 29, 2019 and Mar 26, 2022 — classified as 1 injury, 12 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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.
Most reported problems
Device problems
- Fluid/Blood Leak8
- Material Deformation3
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "THERE HAVE BEEN REPORTED INSTANCES THAT THE WINGED INFUSION SET 20G 3/4" HUBER NEEDLE HAS CRACKED." IT WAS REPORTED THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13920852 ↗MalfunctionMar 25, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "THERE HAVE BEEN REPORTED INSTANCES THAT THE WINGED INFUSION SET 20G 3/4" HUBER NEEDLE HAS CRACKED." IT WAS REPORTED THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13904590 ↗MalfunctionMar 25, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "THERE HAVE BEEN REPORTED INSTANCES THAT THE WINGED INFUSION SET 20G 3/4" HUBER NEEDLE HAS CRACKED." IT WAS REPORTED THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13904579 ↗MalfunctionMar 25, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "THERE HAVE BEEN REPORTED INSTANCES THAT THE WINGED INFUSION SET 20G 3/4" HUBER NEEDLE HAS CRACKED." IT WAS REPORTED THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13904563 ↗MalfunctionMar 25, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "THERE WAS AN INCIDENT REPORTED THAT THE WINGED INFUSION SET 20G 1 HUBER NEEDLE WAS CRACKED AT THE END OF THE TUBING (AT THE LUER)."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13904541 ↗MalfunctionAug 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE NEEDLE DISCONNECTED FROM THE BASE WITH FIXING FINS.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10371115 ↗InjuryJul 31, 2020Material Deformation; Material Deformation
IT WAS REPORTED THE NEEDLE WAS PLACED 3 DAYS IN A CHAMBER IN SUBCLAVIAN POSITION AND IT BROKE AT A RIGHT ANGLE. THE RIGHT PART OF THE NEEDLE WAS FOUND UNDER THE SKIN WHICH REQUIRE SURGICAL INTERVENTION TO EXTRACT AND SUTURE IT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10351139 ↗MalfunctionMar 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT UPON REMOVAL OF THE HUBER NEEDLE, THE NURSE NOTICED THAT THE NEEDLE (METAL PART) WAS DETACHED FROM THE PLASTIC SUPPORT AND THE CHEMOTHERAPY PRODUCT HAS PROBABLY LEAKED ON THE PATIENT'S SKIN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9885355 ↗MalfunctionSep 26, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT A LEAKAGE OCCURS UPON CONNECTION FOR THE DEVICE: WINGED INFUSION SET. ASPIRATION OF AIR THROUGH THE LUER-LOCK CONNECTION. THE PROBLEM OCCURED MULTIPLE TIMES. THE ISSUE HAPPENS AS WELL WITH LUER AS LUER-LOCK CONNECTIONS (E.G. SYRINGE, POSIFLUSH, LUER ADAPTER FOR BLOOD WITHDRAWAL). THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9123061 ↗MalfunctionSep 26, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT A LEAKAGE OCCURS UPON CONNECTION FOR THE DEVICE: WINGED INFUSION SET. ASPIRATION OF AIR THROUGH THE LUER-LOCK CONNECTION. THE PROBLEM OCCURED MULTIPLE TIMES. THE ISSUE HAPPENS AS WELL WITH LUER AS LUER-LOCK CONNECTIONS (E.G. SYRINGE, POSIFLUSH, LUER ADAPTER FOR BLOOD WITHDRAWAL). THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9123057 ↗MalfunctionMay 29, 2019Fluid/Blood Leak
IT IS REPORTED THAT THERE IS A LEAKAGE AT THE LEVEL OF THE NEEDLE/HOSE CONNECTION. USED IN CONJUNCTION WITH ART EMC9657C FROM BAXTER. NO OTHER INFORMATION WAS PROVIDED. IT WAS STATED THAT THREE WINGED INFUSION SETS WERE NOTED TO BE LEAKING. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8651478 ↗MalfunctionMay 29, 2019Fluid/Blood Leak
IT IS REPORTED THAT THERE IS A LEAKAGE AT THE LEVEL OF THE NEEDLE/HOSE CONNECTION. USED IN CONJUNCTION WITH ART EMC9657C FROM BAXTER. NO OTHER INFORMATION WAS PROVIDED. IT WAS STATED THAT THREE WINGED INFUSION SETS WERE NOTED TO BE LEAKING. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8651473 ↗MalfunctionMay 29, 2019Fluid/Blood Leak
IT IS REPORTED THAT THERE IS A LEAKAGE AT THE LEVEL OF THE NEEDLE/HOSE CONNECTION. USED IN CONJUNCTION WITH ART EMC9657C FROM BAXTER. NO OTHER INFORMATION WAS PROVIDED. IT WAS STATED THAT THREE WINGED INFUSION SETS WERE NOTED TO BE LEAKING. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8651470 ↗
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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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