Port Access Needle 2206222Recalls & reported problems
Bard Access Systems, Inc. · Winged Infusion Set 22G x 1 inch with y-site · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741065903), received between Jan 10, 2019 and Jul 18, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 Leak2
- Component Missing1
- Leak/Splash1
- Mechanical Problem1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2019Fluid/Blood Leak; Mechanical Problem; Component Missing
IT WAS REPORTED THAT WHEN THE WIS WAS OPENED, IT WAS NOTED THAT CONNECTOR ON ONE OF THE PORT WAS MISSING AND HENCE DIDN¿T USE THE NEEDLE. THEY TRIED CLOSING THE NEEDLE WITH REGULAR END CAP BUT DIDN¿T FIND IT TIGHT ENOUGH AS SALINE WAS LEAKING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8804260 ↗MalfunctionMar 21, 2019Leak/Splash
IT WAS REPORTED THAT LEAKAGE OCCURRED BETWEEN THE LURE CONNECTER OF THE SIDE INJECTION TUBE AND THE INFUSION LINE. THE INFUSION LINE WAS RE-CONNECTED TO THE LUER CONNECTOR OF MAIN INJECTION TUBE AT Y-SITE. AFTER RE-CONNECTED THE LINE, THE INFUSION COULD BE COMPLETED WITHOUT LEAKING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8441844 ↗MalfunctionJan 10, 2019Fluid/Blood Leak
IT WAS REPORTED THAT DURING INFUSION OF THE ANTICANCER AGENT, LEAKAGE OCCURRED AT THE CONNECTION PART OF THE INFUSION LINE AND THE PORT ACCESS NEEDLE. ALTHOUGH THE INFUSION LINE WAS EXCHANGED FOR A NEW ONE, LEAKAGE WAS NOT RESOLVED. THE PHYSICIAN REPLACED BOTH THE INFUSION LINE AND THE NEEDLE TO NEW ONES. THEREFORE, THE INFUSION OF ANTICANCER AGENT COULD BE COMPLETED WITHOUT LEAKING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8235851 ↗
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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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