Portex 100/815/070Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019315045349), received between Jun 27, 2019 and Jun 20, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2023Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT WHILE INFLATING THE CUFF ON THE PATIENT'S TRACH, THEY WERE UNABLE TO INFLATE THE CUFF AND FOUND THE CUFF TO BE ?BLOWN". THE EVENT OCCURRED ON THE CRITICAL CARE FLOOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER. CUSTOMER REPORTED: "THERE WAS NO MEDICAL INTERVENTION, THERE WAS NO PATIENT HARM". A1: ONE PATIENT, TWO PRODUCT MALFUNCTIONS. (B)(6) REPRESENT THE SAME PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162445 ↗
• MalfunctionJun 20, 2023Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT WHILE INFLATING THE CUFF ON THE PATIENT'S TRACH, THEY WERE UNABLE TO INFLATE THE CUFF AND FOUND THE CUFF TO BE BLOWN". THE EVENT OCCURRED ON THE CRITICAL CARE FLOOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162443 ↗
• MalfunctionSep 16, 2022Inflation Problem; Material Split, Cut or Torn; Inflation Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING CUFF TESTING, PRIOR TO USE, THE PRODUCT PRESENTED A BUBBLE INDICATING A TEAR IN THE CUFF OR BALLOON. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436632 ↗
• InjuryJun 27, 2019Labelling, Instructions for Use or Training Problem; Inadequacy of Device Shape and/or Size; Labelling, Instructions for Use or Training Problem; Inadequacy of Device Shape and/or Size

  INFORMATION WAS RECEIVED THAT A PATIENT'S RESPIRATORY CARE TEAM OPENED A "#7 (OUTER PACKAGE)" SMITHS MEDICAL PORTEX BLUE LINE ULTRA CUFFED TRACHEOSTOMY TUBE AND REQUIRED AN EMERGENT PLACEMENT INTO THE PATIENT. AFTER APPROXIMATELY 5-10 MINUTES IN USE, IT WAS NOTICED THAT THE TRACHEOSTOMY (TRACH) HAD A "NUMBER SIX IMPRINTED ON IT, AND THE INNER PACKAGE OF THE DEVICE SAID #6". THE HOSPITAL CARE TEAM (DOCTORS WERE REPORTED TO THE IN THE ROOM AS WELL) NOTED THAT THE PATIENT'S VITAL SIGNS APPEARED NORMAL, BUT THEIR "SAT WAS 90-94%". SUBSEQUENTLY, THE PATIENT DECANNULATED AND THEIR TRACH WAS REPLACED. IT WAS STATED THE PATIENT "TOLERATED WELL" AND THEIR SATURATION ONCE THE PATIENT WAS BACK ON A VENTILATOR OF AN UNKNOWN BRAND WAS 99-100%. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 8741529 ↗