Portex 197-39RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019315058578), received between May 19, 2021 and May 19, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (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 18, 2026.

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.

• MalfunctionMay 19, 2021Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED A SMITHS MEDICAL INTUBATION/PORTEX ENDOBRONCHIAL TUBES MALFUNCTIONED. IT WAS REPORTED THE TUBE WAS UNPACKED FROM STERILE PACKAGING AND THE CUFF TESTED FOR LEAKAGE. THE MANDRIN WAS THEN REMOVED FOR LUBRICATION, WHEN THE CUSTOMER NOTED THAT THE MANDRIN GLIDES VERY SLOWLY ,BOTH BEFORE AND AFTER APPLIED LUBRICANT. THEN THE TUBE WAS MORE THOROUGHLY EXAMINED IT WAS THEN DISCOVERED A CLAMPING DISTAL TO THE TRACHEAL CUFF. THE TUBE WAS THEREFORE NOT ATTEMPTED USED AND A NEW ONE WAS RETRIEVED. PICTURES WERE ATTACHED. NO PATIENT INVOLVEMENT OR ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852638 ↗