Port Access Needle SHG20-75YRecalls & reported problems
Bard Access Systems, Inc. · EZ Huber 20ga x 3/4in · Class 2
All models of Port Access Needle (122)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741089244), received between Mar 4, 2020 and Mar 4, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Crack1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2020Crack; Crack
IT WAS REPORTED THE EZ HUBER WAS PRIMED AND CONNECTED TO PATIENTS PORT. THE CHEMOTHERAPY INFUSION STARTED AND WAS DUE TO LAST FOR 2 HOURS. DURING THE LAST 30 MINUTES, THE PATIENT COMPLAINED OF DAMP CLOTHING IN THE SURROUNDING AREA OF THE PORT. THE NURSE IMMEDIATELY DISCONNECTED THE INFUSION PUMP FROM THE EZ HUBER. SHE THEN UNSCREWED THE GREEN NEEDLE FREE BUNG ON THE SECONDARY ARM OF THE HUBER NEEDLE EXTENSION. A SMALL CRACK WAS OBSERVED JUST BELOW THE LUER LOCK PART OF THE EXTENSION LINE. THE NURSE THEN USED SALINE TO FLUSH THE ARM TO CONFIRM THE CRACK AND THEN SAW THE SALINE SQUIRT OUT OF THE CRACK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9788927 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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