Port Access Needle SHG22-75Recalls & reported problems
Bard Access Systems, Inc. · EZ Huber 22ga x 3/4in · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741089336), received between Mar 17, 2023 and May 10, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (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 16, 2026.
Most reported problems
Device problems
- Activation Problem1
- Failure to Infuse1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 10, 2023Activation Problem; Activation Problem
IT WAS REPORTED ON REMOVING THE SAFESTEP HUBER NEEDLE FROM AN ACCESSED PORTACATH, THE SAFETY GUARD FAILED TO DEPLOY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16902124 ↗MalfunctionMar 17, 2023Failure to Infuse; Failure to Infuse
IT WAS REPORTED BY THE CUSTOMER ¿NEEDLE WAS USED FOR A PATIENT WHO WAS DISCHARGED WITH AN INFUSIONAL 5FU PUMP IN PROGRESS WHICH CEASED INFUSING IN THE SUBSEQUENT DAYS, WHEN THERE HAD BEEN NO ISSUES WITH THE PORT PRIOR. UPON REVIEW THE DISTRICT NURSE WAS AGAIN UNABLE TO FLUSH VIA THE EZ HUBER NEEDLE.¿ IT WAS STATED THE PATIENT MISSED A SMALL AMOUNT OF CHEMOTHERAPY DOSAGE AS A RESULT. THE DEVICE WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16565707 ↗
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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 13, 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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