Portex Z110N-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15019315058868), received between Nov 21, 2018 and Feb 6, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE PORT WAS TORN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326557 ↗
• MalfunctionDec 13, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WERE SEVERAL CRACKS ON THE DEVICE THAT CAUSED LEAKS. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925617 ↗
• MalfunctionSep 22, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE RESPIRATORY AIDE FOUND THAT A PART FROM THE INLINE SUCTION SYSTEM WAS MISSING IN THE PACKAGE. THIS WAS NOTICED IMMEDIATELY UPON USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15468982 ↗
• InjuryJan 28, 2021Break; Break

  INFORMATION WAS RECEIVED INDICATING THAT DURING SUCTIONING OF A COVID PATIENT, THE PORTEX CATHETERS SUCTION BROKE IN TWO PIECES. A REPLACEMENT OF THE VENTILATOR CIRCUIT AND MANUAL HAND VENTILATION IN MEANTIME WAS PERFORMED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11244257 ↗
• InjuryOct 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED THE INLINE SUCTION PORTION OF A SMITHS MEDICAL PORTEX SUCTION CATHETER SNAPPED AND BROKE WHILE IN USE WITH A PATIENT. THIS RESULTED IN A SMALL LACERATION ON THE CLINICIAN'S INDEX FINGER, AS WELL AS A HEART RATE INCREASE OF THE PATIENT TO 120S AND SAO2 DECREASE TO 59 PERCENT. THE PATENT WAS MANUALLY BAGGED UNTIL SAO2 INCREASED INTO THE 90S. ADDIITONALLY, THE RT CALLED FOR A NEW INLINE SUCTION PART. NO PATIENT INJURY RESULTED.

  Patient problems: Low Oxygen Saturation; No Consequences Or Impact To Patient

  MAUDE report 9176419 ↗
• MalfunctionNov 21, 2018Obstruction of Flow; Obstruction of Flow

  INFORMATION WAS RECEIVED INDICATING THAT DURING SUCTIONING OF A PATIENT WITH A SMITHS MEDICAL PORTEX® SUCTIONPRO 72¿ THE BLUE PLASTIC THUMB CONTROL IS NOTED TO BE OCCLUDING THE SUCTION PORT. IT WAS REPORTED THAT WHEN THE BLUE PIECE OF THE SUCTION UNIT WAS PULLED FORWARD, IT HAD OCCLUDED THE SUCTION OUTLET. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8096758 ↗