Portex 100/870/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 15019315038808), received between Apr 2, 2020 and Mar 19, 2024 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT CUFF CAN'T INFLATE. EVENT OCCURRED IMMEDIATELY ON USE, IN THE HOSPITAL. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18937498 ↗
• MalfunctionSep 16, 2022Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE, THE CUSTOMER NOTICED NO INNER CANNULA WAS ENCLOSED IN IT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436733 ↗
• MalfunctionSep 6, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS UNABLE TO INFLATE PRIOR TO INSERTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363885 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT THIS ID THE FIRST OCCURRENCE: THOUGHT TO BE A "ONE-OFF" SITUATION SO WAS NOT INITIALLY REPORTED. ONCE THE DEVICE WAS INFLATED IN SITUATION, IT POPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12864469 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT THIS WAS THE SECOND OCCURRENCE: THE KIT WAS CHECKED PRE-USE BY THE NURSE, NO ABNORMALITIES NOTED. ONCE THE DEVICE WAS INFLATED IN SITUATION, IT POPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12864366 ↗
• InjuryApr 22, 2021Crack; Crack

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) TIP OF THE SUB GLOTTIC PORT HAS CRACKED. PATIENT REQUIRED IMMEDIATE TRACHEOSTOMY CHANGE OUT.

  Patient problems: Airway Obstruction

  MAUDE report 11711947 ↗
• InjuryDec 9, 2020Gas/Air Leak; Gas/Air Leak

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) WOULD NOT HOLD PRESSURE. THE CUSTOMER CONFIRMED IN A PRE-USE CHECK THAT THE PRODUCT WORKED PROPERLY. HE THEN STARTED TO USE IT WITH 30 MMHG OF AIR PRESSURE APPLIED TO ITS CUFF. HOWEVER, IN 30 MINUTES OR SO, THE PRESSURE DECREASED TO 7-10 MMHG. AS THIS EVENT WAS REPEATEDLY OBSERVED, HE CHANGED THE PRODUCT TO ANOTHER ONE IN ONE (1) DAY AFTER STARTING TO USE THE FIRST ONE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10979240 ↗
• MalfunctionDec 9, 2020Gas/Air Leak; Gas/Air Leak

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) WOULD NOT HOLD PRESSURE. THE CUSTOMER CONFIRMED IN A PRE-USE CHECK THAT THE PRODUCT WORKED PROPERLY. HE THEN STARTED TO USE IT WITH 30 MMHG OF AIR PRESSURE APPLIED TO ITS CUFF. HOWEVER, IN 30 MINUTES OR SO, THE PRESSURE DECREASED TO 7-10 MMHG. AS THIS EVENT WAS REPEATEDLY OBSERVED, HE CHANGED THE PRODUCT TO ANOTHER ONE IN ONE (1) DAY AFTER STARTING TO USE THE FIRST ONE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10978458 ↗
• InjuryNov 20, 2020Material Puncture/Hole; Material Puncture/Hole

  INFORMATION WAS RECEIVE INDICATING THAT THE PORTEX TUBES BLUE LINE ULTRA WORKED PROPERLY DURING THE PRE-USE CHECK, BUT DURING THE USE OF THE PRODUCT THE CUFF DID NOT INFLATE AND HAD A PINHOLE IN IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10876523 ↗
• MalfunctionSep 16, 2020Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  INFORMATION RECEIVED ON A SMITH MEDICAL TRACHEOSTOMY/PVC, PORTEX TUBES BLUE LINE ULTRA (BLU) MALFUNCTIONED. NO ANOMALY IN THE PRODUCT WAS OBSERVED AT A PRE-USE CHECK. HOWEVER, AFTER INDWELLING IT IN THE PATIENT FOR A WHILE, THE CUSTOMER NOTICED THE CUFF DEFLATED AND SLIPPED OFF FROM THE PATIENT. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10538993 ↗
• MalfunctionAug 29, 2020Inflation Problem; Tear, Rip or Hole in Device Packaging; Gas/Air Leak; Inflation Problem; Tear, Rip or Hole in Device Packaging; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF COMPONENT OF THE BLUE LINE ULTRA (BLU) TRACHEOSTOMY TUBE WAS DEFLATING TOO EASILY. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

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

  MAUDE report 10469704 ↗
• MalfunctionAug 27, 2020Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF COMPONENT OF THE BLUE LINE ULTRA (BLU) TRACHEOSTOMY TUBE WAS DEFLATING TOO EASILY. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Information

  MAUDE report 10461508 ↗
• MalfunctionAug 7, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUFF COMPONENT OF THE PORTEX TRACHEOSTOMY TUBE EASILY DEFLATED DURING USE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10379372 ↗
• InjuryApr 2, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE WAS REPORTED TO BE LEAKING TWO HOURS AFTER PLACEMENT. A TRACH TUBE CHANGE OUT WAS PERFORMED WITH NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9919204 ↗