Introducer Needle 5584180Recalls & reported problems
Bard Access Systems, Inc. · Introducer Needle 18 ga · Class 2
Data updated Oct 13, 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 00801741045134), received between Dec 28, 2021 and Dec 28, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Deformation Due to Compressive Stress1
- Fluid/Blood Leak1
- Fracture1
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.
MalfunctionDec 28, 2021Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress
IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE IN THE SUBCLAVIAN VEIN, THE PINK HUB ATTACHED TO THE INTRODUCER NEEDLE WAS ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE NEEDLE ALLEGEDLY LEAKED ON THE OUTSIDE WHICH IN TURN DELAYED THE TREATMENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13095674 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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