Port Access Needle SHG19-75YRecalls & reported problems
Bard Access Systems, Inc. · EZ Huber 19ga 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 00801741089145), received between May 3, 2024 and May 3, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Crack1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 3, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED, "IN THE MORNING, THE TUBE WAS FILLED WITH AIR. RINSING WITH NACL 0.9% AND ASPIRATION OF BLOOD WAS NOT POSSIBLE. DURING RINSING, RINSING FLUID LEAKED FROM THE Y-PIECE. AS WE DID NOT NOTICE THE DEFECT IMMEDIATELY, WE TRIED TO FLUSH AGAIN AT THE SMALL ACCESS OF THE Y-PIECE. THE FLUSHING FLUID ESCAPED IN A JET FROM THE SIDE OF THE HOSE. WE STOPPED IMMEDIATELY AND CLOSED THE CLAMP NEAR THE PORT NEEDLE." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19240400 ↗
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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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