Portex 100/189/085Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 15019315059551), received between Apr 25, 2019 and Dec 12, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHEN THE CUSTOMER PUT AIR IN THE CUFF DURING THE PRE-USE CHECK, LEAKAGE OF AIR FROM IT WAS OBSERVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15960822 ↗
• MalfunctionSep 15, 2022Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT TEN DAYS AFTER THE START OF USE, THE SUCTION LINE GOT TORN OFF AT A POINT APPROXIMATELY 2 CENTIMETERS AWAY FROM THE TUBING CONNECTION PART. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15434498 ↗
• MalfunctionAug 2, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE BLUE 15MM CONNECTOR KEPT DISCONNECTING FROM THE TRACHEAL TUBE. THE TIP WAS NOT DEEP ENOUGH INSIDE THE TUBE AND JUST DISCONNECTS. NO CLINICAL CONSEQUENCE, ISSUE OCCURRED UPON OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15154283 ↗
• MalfunctionApr 13, 2022Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE BALLOON DEFLATED MORE OFTEN THAN USUAL. THE USER HAD TO RE-INFLATE IT EVERY 4 HOURS AND SOMETIMES THE USER HAD TO PUT A CAP ON TO LIMIT LEAKAGE. IT WAS CONFIRMED THAT THE USER USED RUSH "SILICOSPRAY". NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102339 ↗
• MalfunctionFeb 26, 2020Break; Material Integrity Problem; Break; Material Integrity Problem

  INVESTIGATION COMPLETED ON A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBE. SUMMARY IN H 10.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9753503 ↗
• MalfunctionFeb 26, 2020Break; Power Problem; Break; Power Problem

  IT WAS REPORTED THE UNIT WAS FOUND TO HAVE NO POWER AND A SUSPECTED BROKEN SWITCH CONNECTION. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 09 MARCH 2020. THE PRODUCT PROBLEM WAS OBSERVED DURING TESTING. THE UNIT DID NOT PROVIDE AN ALARM BECAUSE IT WAS NOT TURNING ON AT ALL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9753496 ↗
• InjuryApr 25, 2019Connection Problem; Connection Problem

  INFORMATION WAS RECEIVED THAT AFTER INTUBATION OF A A SMITHS MEDICAL PORTEX (SACETT) SUCTION ABOVE THE CUFF TRACHEAL TUBE, THE INFLATION LINE PULLED OUT OF THE TUBE WHEN THE CUSTOMER INFLATED THE CUFF. SUBSEQUENTLY, A TRACH TUB CHANGE OUT WAS REQUIRED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8553433 ↗