Portex 100/562/000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019315042829), received between Sep 23, 2021 and Sep 23, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  INFORMATION WAS RECEIVED INDICATING THAT THE GUIDE WIRE OF A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT ULTRAPERC WOULD KINK DURING PLACEMENT, MAKING IT VERY DIFFICULT TO PLACE. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12520537 ↗
• MalfunctionSep 23, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  INFORMATION WAS RECEIVED INDICATING THAT THE GUIDE WIRE OF A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT ULTRAPERC WOULD KINK DURING PLACEMENT, MAKING IT VERY DIFFICULT TO PLACE. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12520509 ↗
• MalfunctionSep 23, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  INFORMATION WAS RECEIVED INDICATING THAT THE GUIDE WIRE OF A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT ULTRAPERC WOULD KINK DURING PLACEMENT, MAKING IT VERY DIFFICULT TO PLACE. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12520316 ↗
• MalfunctionSep 23, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  INFORMATION WAS RECEIVED INDICATING THAT THE GUIDE WIRE OF A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT ULTRAPERC WOULD KINK DURING PLACEMENT, MAKING IT VERY DIFFICULT TO PLACE. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519668 ↗
• MalfunctionSep 23, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  INFORMATION WAS RECEIVED INDICATING THAT THE GUIDE WIRE OF A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT ULTRAPERC WOULD KINK DURING PLACEMENT, MAKING IT VERY DIFFICULT TO PLACE. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519505 ↗