Perifix® 332217Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964178283), received between Sep 21, 2023 and Feb 2, 2024 — classified as 2 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 5, 2023Open, Classified

   Kits were assembled with the incorrect Filter Straw.

   Z-2002-2023 · Root cause: Mixed-up of materials/components · FDA record ↗

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.

• MalfunctionFeb 2, 2024Break; Break

  AS REPORTED BY THE USER FACILITY: THE EPIDURAL NEEDLE BROKE OFF INTO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18631889 ↗
• MalfunctionSep 21, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: END OF CATHETER BLUE TIP SHEARED OFF. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17790332 ↗