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MicroEZ Introducer 0828945Recalls & reported problems

Bard Access Systems, Inc. · Univ MI, 4.5 Fr, 7cm, · Class 2

All models of MicroEZ Introducer (12)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741074653), received between May 6, 2016 and May 6, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Bent” (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

  • Bent1
  • Failure to Advance1
  • Knotted1
  • Physical Resistance1

Patient problems

  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 6, 2016Bent; Knotted; Failure to Advance; Physical Resistance

    ON (B)(6) 2016 ¿ PER (B)(6), A FACILITY CONTACT REPORTED THAT ONE OF THEIR PICC NURSES WAS ATTEMPTING TO PLACE A POWERPICC 3CG. THE NURSE PLACED THE 21 GA INTRODUCER NEEDLE AND THE 0.018" WIRE BUT WHEN SHE TRIED TO ADVANCE THE WIRE, IT MET RESISTANCE. THE NURSE REMOVED THE WIRE AND REPORTED THAT IT WAS BENT. SHE OBTAINED ANOTHER WIRE, PASSED IT AND AGAIN HIT RESISTANCE. SHE THEN ATTEMPTED TO REMOVE THE WIRE BUT WAS UNABLE TO BECAUSE IT BECAME STUCK. THE REPORTING CONTACT, WHO SPOKE WITH (B)(6) AND IS ALSO A NURSE, VISITED THE FACILITY WHERE THIS OCCURRED AND DETERMINED THAT THE WIRE WAS STUCK IN THE TISSUE OF THE ARM AT THE NEEDLE INSERTION SITE. THE CONTACT THEN MADE A SMALL CUT AND THE WIRE CAME OUT. IT WAS NOTED THAT THE WIRE WAS IN A LOOSE KNOT ON THE END. A MIDLINE WAS PLACED INTO THE PATIENT¿S OTHER ARM.

    Patient problems: No Information

    MAUDE report 5638142 ↗

Other INTRODUCER, CATHETER devices

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Sources and updates

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