DAR 353S19046Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521779372), received between Sep 28, 2023 and Sep 28, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

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. Apr 29, 2021Open, Classified

   The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.

   Z-1869-2021 · Root cause: Material/Component Contamination · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionSep 28, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE PATIENT WAS TRANSFERRED TO THE MRI PRIOR TO PRODUCT PLACEMENT. UPON RETURN TO THE ROOM AFTER THE EXAMINATION, THE DEVICE WAS CONNECTED TO A CLOSED SUCTION CATHETER TRACH CARE AND USED. IT WAS FOUND THAT THE OFP'S SILICONE FILM HAD FALLEN OUT IN THE L-SHAPED PART OF THE TRACH CARE AND IT WAS COLLECTED. IT WAS CHECKED THAT THE DEVICE WAS REPLACED ONCE EVERY 24 HOURS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839798 ↗