Ballard* Closed Suction System for Adults 92470Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00609038924700), received between Mar 31, 2023 and Mar 31, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THERE WAS AN "EXTRA PIECE OF PLASTIC APPEARS TO BE BROKEN, OR A PORTION OF IT IS MISSING. STAFF UNSURE IF THIS PIECE OF PLASTIC WAS DISLODGED INTO THE PATIENT'S AIRWAY WHEN ATTEMPTING TO SUCTION THE PATIENT WITH THE DEVICE...NO PATIENT HARM REPORTED ON SUNDAY MARCH 5TH A DEFECTIVE INLINE SUCTION CATHETER WAS DISCOVERED ON A PATIENT. IT LOOKS AS THOUGH THIS BALLARD HAS AND EXTRA PIECE OF PLASTIC THAT COVERED THE WHOLE AREA OF WHERE IT WOULD CONNECT TO THE ETT [ENDOTRACHEAL TUBE]. THE NURSE AND THE RT [RESPIRATORY THERAPIST] WHERE NOT ABLE TO PASS THE SUCTION CATHETER THROUGH." ADDITIONAL INFORMATION RECEIVED 08-MAR-2023 STATED THE DEVICE WAS USE FOR APPROXIMATELY 2-HOURS. THE USER REPORTS THE DEVICE WAS NOT ALTERED IN ANYWAY PRIOR TO THE REPORTED INCIDENT OCCURRING. THE PATIENT HAD A BRONCHOSCOPY COMPLETED, THERE WERE NO FINDINGS OF ANY FOREIGN OBJECT.

  Patient problems: Insufficient Information

  MAUDE report 16655994 ↗