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Portex 526070Recalls & reported problems

Icu Medical, Inc. · Class 2

Adverse event reports
20
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10351688041135), received between Jan 23, 2019 and Jul 19, 2019 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Accessory Incompatible” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Accessory Incompatible19
  • Connection Problem19
  • Detachment of Device or Device Component1

Patient problems

  • No Consequences Or Impact To Patient19
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 19, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT LATCH INTO PLACE IMMEDIATELY UPON USE. IT WAS NOTED THAT THE PATIENT'S DAUGHTER IS A CERTIFIED PEDIATRIC NURSE AND "SHE HELPED HER OUT" AT THE TIME OF THE EVENT. THE REPORTER ALSO STATED THE PATIENT'S TRACHEOSTOMY TUBE "IS CHANGED MONTHLY AT DOCTOR'S ORDER. WE DID NOT HAVE TO CHANGE IT DUE TO THE CANNULA NOT SNAPPING. THE CANNULA WAS CHANGED TWICE A DAY TO DECREASE RISK OF INFECTIONS AND TO MAINTAIN PATENCY OF THE AIRWAY". FOUR ROUTINE TUBE CHANGE OUTS WERE COMPLETED SINCE THE START OF THE EVENT TO PRESENT TIME (JULY). THE DAUGHTER REPORTED THEY HAD THE SAME PROBLEM OF THE CANNULAS NOT SNAPPING EVEN WITH A NEW TUBE. SUBSEQUENTLY, DUE TO THE REPORTER NOTING THE PATIENT HAD RUN LOW ON A SUPPLY OF CANNULAS, SOME CANNULAS HAD TO BE CLEANED, BOILED, AND RE-USED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8809289 ↗
  • MalfunctionJul 19, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT LATCH INTO PLACE IMMEDIATELY UPON USE. IT WAS NOTED THAT THE PATIENT'S DAUGHTER IS A CERTIFIED PEDIATRIC NURSE AND "SHE HELPED HER OUT" AT THE TIME OF THE EVENT. THE REPORTER ALSO STATED THE PATIENT'S TRACHEOSTOMY TUBE "IS CHANGED MONTHLY AT DOCTOR'S ORDER. WE DID NOT HAVE TO CHANGE IT DUE TO THE CANNULA NOT SNAPPING. THE CANNULA WAS CHANGED TWICE A DAY TO DECREASE RISK OF INFECTIONS AND TO MAINTAIN PATENCY OF THE AIRWAY". FOUR ROUTINE TUBE CHANGE OUTS WERE COMPLETED SINCE THE START OF THE EVENT TO PRESENT TIME (JULY). THE DAUGHTER REPORTED THEY HAD THE SAME PROBLEM OF THE CANNULAS NOT SNAPPING EVEN WITH A NEW TUBE. SUBSEQUENTLY, DUE TO THE REPORTER NOTING THE PATIENT HAD RUN LOW ON A SUPPLY OF CANNULAS, SOME CANNULAS HAD TO BE CLEANED, BOILED, AND RE-USED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8809288 ↗
  • MalfunctionJul 19, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT LATCH INTO PLACE IMMEDIATELY UPON USE. IT WAS NOTED THAT THE PATIENT'S DAUGHTER IS A CERTIFIED PEDIATRIC NURSE AND "SHE HELPED HER OUT" AT THE TIME OF THE EVENT. THE REPORTER ALSO STATED THE PATIENT'S TRACHEOSTOMY TUBE "IS CHANGED MONTHLY AT DOCTOR'S ORDER. WE DID NOT HAVE TO CHANGE IT DUE TO THE CANNULA NOT SNAPPING. THE CANNULA WAS CHANGED TWICE A DAY TO DECREASE RISK OF INFECTIONS AND TO MAINTAIN PATENCY OF THE AIRWAY". FOUR ROUTINE TUBE CHANGE OUTS WERE COMPLETED SINCE THE START OF THE EVENT TO PRESENT TIME (JULY). THE DAUGHTER REPORTED THEY HAD THE SAME PROBLEM OF THE CANNULAS NOT SNAPPING EVEN WITH A NEW TUBE. SUBSEQUENTLY, DUE TO THE REPORTER NOTING THE PATIENT HAD RUN LOW ON A SUPPLY OF CANNULAS, SOME CANNULAS HAD TO BE CLEANED, BOILED, AND RE-USED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8809286 ↗
  • MalfunctionJul 19, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT LATCH INTO PLACE IMMEDIATELY UPON USE. IT WAS NOTED THAT THE PATIENT'S DAUGHTER IS A CERTIFIED PEDIATRIC NURSE AND "SHE HELPED HER OUT" AT THE TIME OF THE EVENT. THE REPORTER ALSO STATED THE PATIENT'S TRACHEOSTOMY TUBE "IS CHANGED MONTHLY AT DOCTOR'S ORDER. WE DID NOT HAVE TO CHANGE IT DUE TO THE CANNULA NOT SNAPPING. THE CANNULA WAS CHANGED TWICE A DAY TO DECREASE RISK OF INFECTIONS AND TO MAINTAIN PATENCY OF THE AIRWAY". FOUR ROUTINE TUBE CHANGE OUTS WERE COMPLETED SINCE THE START OF THE EVENT TO PRESENT TIME (JULY). THE DAUGHTER REPORTED THEY HAD THE SAME PROBLEM OF THE CANNULAS NOT SNAPPING EVEN WITH A NEW TUBE. SUBSEQUENTLY, DUE TO THE REPORTER NOTING THE PATIENT HAD RUN LOW ON A SUPPLY OF CANNULAS, SOME CANNULAS HAD TO BE CLEANED, BOILED, AND RE-USED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8809285 ↗
  • MalfunctionJul 19, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT LATCH INTO PLACE IMMEDIATELY UPON USE. IT WAS NOTED THAT THE PATIENT'S DAUGHTER IS A CERTIFIED PEDIATRIC NURSE AND "SHE HELPED HER OUT" AT THE TIME OF THE EVENT. THE REPORTER ALSO STATED THE PATIENT'S TRACHEOSTOMY TUBE "IS CHANGED MONTHLY AT DOCTOR'S ORDER. WE DID NOT HAVE TO CHANGE IT DUE TO THE CANNULA NOT SNAPPING. THE CANNULA WAS CHANGED TWICE A DAY TO DECREASE RISK OF INFECTIONS AND TO MAINTAIN PATENCY OF THE AIRWAY". FOUR ROUTINE TUBE CHANGE OUTS WERE COMPLETED SINCE THE START OF THE EVENT TO PRESENT TIME (JULY). THE DAUGHTER REPORTED THEY HAD THE SAME PROBLEM OF THE CANNULAS NOT SNAPPING EVEN WITH A NEW TUBE. SUBSEQUENTLY, DUE TO THE REPORTER NOTING THE PATIENT HAD RUN LOW ON A SUPPLY OF CANNULAS, SOME CANNULAS HAD TO BE CLEANED, BOILED, AND RE-USED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8809284 ↗
  • MalfunctionJul 19, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT LATCH INTO PLACE IMMEDIATELY UPON USE. IT WAS NOTED THAT THE PATIENT'S DAUGHTER IS A CERTIFIED PEDIATRIC NURSE AND "SHE HELPED HER OUT" AT THE TIME OF THE EVENT. THE REPORTER ALSO STATED THE PATIENT'S TRACHEOSTOMY TUBE "IS CHANGED MONTHLY AT DOCTOR'S ORDER. WE DID NOT HAVE TO CHANGE IT DUE TO THE CANNULA NOT SNAPPING. THE CANNULA WAS CHANGED TWICE A DAY TO DECREASE RISK OF INFECTIONS AND TO MAINTAIN PATENCY OF THE AIRWAY". FOUR ROUTINE TUBE CHANGE OUTS WERE COMPLETED SINCE THE START OF THE EVENT TO PRESENT TIME (JULY). THE DAUGHTER REPORTED THEY HAD THE SAME PROBLEM OF THE CANNULAS NOT SNAPPING EVEN WITH A NEW TUBE. SUBSEQUENTLY, DUE TO THE REPORTER NOTING THE PATIENT HAD RUN LOW ON A SUPPLY OF CANNULAS, SOME CANNULAS HAD TO BE CLEANED, BOILED, AND RE-USED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8809283 ↗
  • MalfunctionJul 19, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT LATCH INTO PLACE IMMEDIATELY UPON USE. IT WAS NOTED THAT THE PATIENT'S DAUGHTER IS A CERTIFIED PEDIATRIC NURSE AND "SHE HELPED HER OUT" AT THE TIME OF THE EVENT. THE REPORTER ALSO STATED THE PATIENT'S TRACHEOSTOMY TUBE "IS CHANGED MONTHLY AT DOCTOR'S ORDER. WE DID NOT HAVE TO CHANGE IT DUE TO THE CANNULA NOT SNAPPING. THE CANNULA WAS CHANGED TWICE A DAY TO DECREASE RISK OF INFECTIONS AND TO MAINTAIN PATENCY OF THE AIRWAY". FOUR ROUTINE TUBE CHANGE OUTS WERE COMPLETED SINCE THE START OF THE EVENT TO PRESENT TIME (JULY). THE DAUGHTER REPORTED THEY HAD THE SAME PROBLEM OF THE CANNULAS NOT SNAPPING EVEN WITH A NEW TUBE. SUBSEQUENTLY, DUE TO THE REPORTER NOTING THE PATIENT HAD RUN LOW ON A SUPPLY OF CANNULAS, SOME CANNULAS HAD TO BE CLEANED, BOILED, AND RE-USED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8809282 ↗
  • MalfunctionJul 19, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT LATCH INTO PLACE IMMEDIATELY UPON USE. IT WAS NOTED THAT THE PATIENT'S DAUGHTER IS A CERTIFIED PEDIATRIC NURSE AND "SHE HELPED HER OUT" AT THE TIME OF THE EVENT. THE REPORTER ALSO STATED THE PATIENT'S TRACHEOSTOMY TUBE "IS CHANGED MONTHLY AT DOCTOR'S ORDER. WE DID NOT HAVE TO CHANGE IT DUE TO THE CANNULA NOT SNAPPING. THE CANNULA WAS CHANGED TWICE A DAY TO DECREASE RISK OF INFECTIONS AND TO MAINTAIN PATENCY OF THE AIRWAY". FOUR ROUTINE TUBE CHANGE OUTS WERE COMPLETED SINCE THE START OF THE EVENT TO PRESENT TIME (JULY). THE DAUGHTER REPORTED THEY HAD THE SAME PROBLEM OF THE CANNULAS NOT SNAPPING EVEN WITH A NEW TUBE. SUBSEQUENTLY, DUE TO THE REPORTER NOTING THE PATIENT HAD RUN LOW ON A SUPPLY OF CANNULAS, SOME CANNULAS HAD TO BE CLEANED, BOILED, AND RE-USED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8809281 ↗
  • MalfunctionJul 19, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT LATCH INTO PLACE IMMEDIATELY UPON USE. IT WAS NOTED THAT THE PATIENT'S DAUGHTER IS A CERTIFIED PEDIATRIC NURSE AND "SHE HELPED HER OUT" AT THE TIME OF THE EVENT. THE REPORTER ALSO STATED THE PATIENT'S TRACHEOSTOMY TUBE "IS CHANGED MONTHLY AT DOCTOR'S ORDER. WE DID NOT HAVE TO CHANGE IT DUE TO THE CANNULA NOT SNAPPING. THE CANNULA WAS CHANGED TWICE A DAY TO DECREASE RISK OF INFECTIONS AND TO MAINTAIN PATENCY OF THE AIRWAY". FOUR ROUTINE TUBE CHANGE OUTS WERE COMPLETED SINCE THE START OF THE EVENT TO PRESENT TIME (JULY). THE DAUGHTER REPORTED THEY HAD THE SAME PROBLEM OF THE CANNULAS NOT SNAPPING EVEN WITH A NEW TUBE. SUBSEQUENTLY, DUE TO THE REPORTER NOTING THE PATIENT HAD RUN LOW ON A SUPPLY OF CANNULAS, SOME CANNULAS HAD TO BE CLEANED, BOILED, AND RE-USED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8809277 ↗
  • MalfunctionJul 19, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT LATCH INTO PLACE IMMEDIATELY UPON USE. IT WAS NOTED THAT THE PATIENT'S DAUGHTER IS A CERTIFIED PEDIATRIC NURSE AND "SHE HELPED HER OUT" AT THE TIME OF THE EVENT. THE REPORTER ALSO STATED THE PATIENT'S TRACHEOSTOMY TUBE "IS CHANGED MONTHLY AT DOCTOR'S ORDER. WE DID NOT HAVE TO CHANGE IT DUE TO THE CANNULA NOT SNAPPING. THE CANNULA WAS CHANGED TWICE A DAY TO DECREASE RISK OF INFECTIONS AND TO MAINTAIN PATENCY OF THE AIRWAY". FOUR ROUTINE TUBE CHANGE OUTS WERE COMPLETED SINCE THE START OF THE EVENT TO PRESENT TIME (JULY). THE DAUGHTER REPORTED THEY HAD THE SAME PROBLEM OF THE CANNULAS NOT SNAPPING EVEN WITH A NEW TUBE. SUBSEQUENTLY, DUE TO THE REPORTER NOTING THE PATIENT HAD RUN LOW ON A SUPPLY OF CANNULAS, SOME CANNULAS HAD TO BE CLEANED, BOILED, AND RE-USED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8809276 ↗
  • MalfunctionJul 19, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT LATCH INTO PLACE IMMEDIATELY UPON USE. IT WAS NOTED THAT THE PATIENT'S DAUGHTER IS A CERTIFIED PEDIATRIC NURSE AND "SHE HELPED HER OUT" AT THE TIME OF THE EVENT. THE REPORTER ALSO STATED THE PATIENT'S TRACHEOSTOMY TUBE "IS CHANGED MONTHLY AT DOCTOR'S ORDER. WE DID NOT HAVE TO CHANGE IT DUE TO THE CANNULA NOT SNAPPING. THE CANNULA WAS CHANGED TWICE A DAY TO DECREASE RISK OF INFECTIONS AND TO MAINTAIN PATENCY OF THE AIRWAY". FOUR ROUTINE TUBE CHANGE OUTS WERE COMPLETED SINCE THE START OF THE EVENT TO PRESENT TIME (JULY). THE DAUGHTER REPORTED THEY HAD THE SAME PROBLEM OF THE CANNULAS NOT SNAPPING EVEN WITH A NEW TUBE. SUBSEQUENTLY, DUE TO THE REPORTER NOTING THE PATIENT HAD RUN LOW ON A SUPPLY OF CANNULAS, SOME CANNULAS HAD TO BE CLEANED, BOILED, AND RE-USED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8809275 ↗
  • MalfunctionJul 19, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT LATCH INTO PLACE IMMEDIATELY UPON USE. IT WAS NOTED THAT THE PATIENT'S DAUGHTER IS A CERTIFIED PEDIATRIC NURSE AND "SHE HELPED HER OUT" AT THE TIME OF THE EVENT. THE REPORTER ALSO STATED THE PATIENT'S TRACHEOSTOMY TUBE "IS CHANGED MONTHLY AT DOCTOR'S ORDER. WE DID NOT HAVE TO CHANGE IT DUE TO THE CANNULA NOT SNAPPING. THE CANNULA WAS CHANGED TWICE A DAY TO DECREASE RISK OF INFECTIONS AND TO MAINTAIN PATENCY OF THE AIRWAY". FOUR ROUTINE TUBE CHANGE OUTS WERE COMPLETED SINCE THE START OF THE EVENT TO PRESENT TIME ((B)(6)). THE DAUGHTER REPORTED THEY HAD THE SAME PROBLEM OF THE CANNULAS NOT SNAPPING EVEN WITH A NEW TUBE. SUBSEQUENTLY, DUE TO THE REPORTER NOTING THE PATIENT HAD RUN LOW ON A SUPPLY OF CANNULAS, SOME CANNULAS HAD TO BE CLEANED, BOILED, AND RE-USED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8809274 ↗
  • MalfunctionJul 19, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT LATCH INTO PLACE IMMEDIATELY UPON USE. IT WAS NOTED THAT THE PATIENT'S DAUGHTER IS A CERTIFIED PEDIATRIC NURSE AND "SHE HELPED HER OUT" AT THE TIME OF THE EVENT. THE REPORTER ALSO STATED THE PATIENT'S TRACHEOSTOMY TUBE "IS CHANGED MONTHLY AT DOCTOR'S ORDER. WE DID NOT HAVE TO CHANGE IT DUE TO THE CANNULA NOT SNAPPING. THE CANNULA WAS CHANGED TWICE A DAY TO DECREASE RISK OF INFECTIONS AND TO MAINTAIN PATENCY OF THE AIRWAY". FOUR ROUTINE TUBE CHANGE OUTS WERE COMPLETED SINCE THE START OF THE EVENT TO PRESENT TIME (JULY). THE DAUGHTER REPORTED THEY HAD THE SAME PROBLEM OF THE CANNULAS NOT SNAPPING EVEN WITH A NEW TUBE. SUBSEQUENTLY, DUE TO THE REPORTER NOTING THE PATIENT HAD RUN LOW ON A SUPPLY OF CANNULAS, SOME CANNULAS HAD TO BE CLEANED, BOILED, AND RE-USED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8809273 ↗
  • MalfunctionJul 19, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT LATCH INTO PLACE IMMEDIATELY UPON USE. IT WAS NOTED THAT THE PATIENT'S DAUGHTER IS A CERTIFIED PEDIATRIC NURSE AND "SHE HELPED HER OUT" AT THE TIME OF THE EVENT. THE REPORTER ALSO STATED THE PATIENT'S TRACHEOSTOMY TUBE "IS CHANGED MONTHLY AT DOCTOR'S ORDER. WE DID NOT HAVE TO CHANGE IT DUE TO THE CANNULA NOT SNAPPING. THE CANNULA WAS CHANGED TWICE A DAY TO DECREASE RISK OF INFECTIONS AND TO MAINTAIN PATENCY OF THE AIRWAY". FOUR ROUTINE TUBE CHANGE OUTS WERE COMPLETED SINCE THE START OF THE EVENT TO PRESENT TIME (JULY). THE DAUGHTER REPORTED THEY HAD THE SAME PROBLEM OF THE CANNULAS NOT SNAPPING EVEN WITH A NEW TUBE. SUBSEQUENTLY, DUE TO THE REPORTER NOTING THE PATIENT HAD RUN LOW ON A SUPPLY OF CANNULAS, SOME CANNULAS HAD TO BE CLEANED, BOILED, AND RE-USED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8809272 ↗
  • MalfunctionApr 18, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT CLIP INTO THE PATIENT'S TRACHEOSTOMY TUBE AS THE SNAP WAS NOT HOLDING. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8528652 ↗
  • MalfunctionApr 18, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT CLIP INTO THE PATIENT'S TRACHEOSTOMY TUBE AS THE SNAP WAS NOT HOLDING. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8528651 ↗
  • MalfunctionApr 18, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT CLIP INTO THE PATIENT'S TRACHEOSTOMY TUBE AS THE SNAP WAS NOT HOLDING. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8528645 ↗
  • MalfunctionApr 18, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT CLIP INTO THE PATIENT'S TRACHEOSTOMY TUBE AS THE SNAP WAS NOT HOLDING. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8528644 ↗
  • MalfunctionApr 18, 2019Accessory Incompatible; Connection Problem; Accessory Incompatible; Connection Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA WOULD NOT CLIP INTO THE PATIENT'S TRACHEOSTOMY TUBE AS THE SNAP WAS NOT HOLDING. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8528643 ↗
  • MalfunctionJan 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY TUBE WAS NOT CLICKING INTO THE TRACHEOSTOMY. THE TWO PRODUCTS NOT FITTING TOGETHER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8270157 ↗

Other Tube, tracheostomy (w/wo connector) devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.