BD Introsyte-N 384031Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 50382903840316), received between May 7, 2020 and Jan 13, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2021Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE BD INTROSYTE-N¿ 22 GA (2.8F) EXPERIENCED A BROKEN/SEPARATED SHEATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONNECTOR BROKE IN THE "BUTTERFLY".

  Patient problems: No Patient Involvement

  MAUDE report 11159768 ↗
• MalfunctionMay 7, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD INTROSYTE-N¿ INTRODUCER WAS FOUND CRACKED AND DAMAGED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "CRACK, BREAKAGE OF THE PRODUCT OR PART OF IT (INTRODUCER)."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10034220 ↗