Portex 100/541/080CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 15019315106606), received between Jul 19, 2018 and Mar 18, 2024 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT AN ABNORMALITY IN THE PUNCTURE NEEDLE WAS FOUND DURING USE ON THE PATIENT. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED. THE SAMPLE IS NOT AVAILABLE FOR RETURN AS IT HAS ALREADY BEEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924963 ↗
• MalfunctionMay 5, 2023Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED, THAT IN THE (B)(6) OF THE HOSPITAL. THE DOCTOR EXPERIENCED A RUPTURE OF THE EXPANDING FORCEPS DURING THE OPERATION. THEY WERE REPLACED WITH A DIFFERENT SET OF CATHETERS. SUCCESSFULLY, NO HARM WAS CAUSED. NO APPLICATION WAS TAKEN. AND NO DEVICE WAS USED IN COMBINATION. IMPLANTATION DATE WAS NOT PROVIDED AND RETIREMENT DATE REPORTED AS (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16878156 ↗
• MalfunctionMay 3, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE TUBE CAME INSIDE THE PACKAGE WITH THE CUFF PERFORATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16859988 ↗
• MalfunctionSep 14, 2022Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGE IT WAS VERIFIED THAT THERE WAS NO KIT CLAMP INSIDE THE PACKING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417348 ↗
• InjuryMay 24, 2022Fluid/Blood Leak; Decrease in Pressure; Fluid/Blood Leak; Decrease in Pressure

  IT WAS REPORTED THAT AFTER 15 MINUTES OF USE A PERSISTENT LEAK WAS OBSERVED. A TEST BEFORE INSERTION WAS CARRIED OUT AND NO ISSUE WAS NOTIFIED. A LOSS OF PRESSURE WAS IDENTIFIED. NEEDED TO PERFORM TRACH CHANGE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 14492335 ↗
• MalfunctionFeb 23, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THE DEVICE WAS LEAKING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583580 ↗
• MalfunctionFeb 23, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THE DEVICE WAS LEAKING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583563 ↗
• MalfunctionFeb 23, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THE DEVICE WAS LEAKING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583538 ↗
• MalfunctionJun 8, 2021Crack; Crack

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) MALFUNCTIONED. DUE TO DAILY USE OF 1ST CANNULA (PICTURE ATTACHED) SINCE FEBRUARY 2021 IT IS GOT CRACKED SO WE OPENED A PACK OF 2ND CANNULA (PICTURE ATTACHED) BUT WHILE USING IT WE ARE FACING A PROBLEM, THAT WHILE MOTHER COUGHS IT COMES OUT FROM THE TRACHEOSTOMY KIT AND IT HAPPENS REGULARLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962282 ↗
• MalfunctionMar 28, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED DISCOMFORT AFTER TRACH TUBE WAS INSERTED. CONCERNS ON WHICH SIZE INNER CANNULA IS NEEDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11580284 ↗
• InjuryMar 2, 2021Partial Blockage; Material Twisted/Bent; Partial Blockage; Material Twisted/Bent

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT GRIGGS MALFUNCTIONED, WHICH COULD CAUSE SERIOUS INJURY AND COMPROMISE OF AIRWAY MANAGEMENT. THE REPORT STATED "DURING THE TRACHEOTOMY, IT WAS FOUND THAT THE GUIDE WIRE ELBOW COULD NOT PASS THROUGH DUE TO THE IMPROPER ANASTOMOSIS BETWEEN THE FRONT END COMPONENT OF THE GUIDE WIRE AND THE PUNCTURE NEEDLE, AND THE TRACHEOTOMY COULD NOT BE COMPLETED. EMERGENCY REPLACEMENT OF CVC PUNCTURE NEEDLE AND GUIDEWIRE, THEN OPERATION COMPLETED." NO FURTHER INFORMATION.

  Patient problems: Airway Obstruction

  MAUDE report 11399350 ↗
• InjuryApr 16, 2019Output Problem; Output Problem

  IT WAS REPORTED THAT THE CANNULA OF A SMITHS MEDICAL TRACHEOSTOMY KIT PRESENTED A SPONTANEOUS BREAKDOWN OF THE EXTENSION CUFF. A REPLACEMENT DEVICE WAS THEN USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8519695 ↗
• MalfunctionJul 19, 2018Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  IT WAS REPORTED THAT THE BLUE LINE ULTRA PERCUTANEOUS TRACHEOSTOMY BALLOON WAS PERFORATED. IN A TEST PERFORMED ON THE CANNULA, IT WAS CONFIRMED THE LEAKAGE WAS FROM THE CUFF. NO DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7703769 ↗