Ballard* Closed Suction System 93896Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00609038938967), received between Aug 13, 2021 and Aug 13, 2021 — 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 16, 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.

• MalfunctionAug 13, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED VIA FDA UFR (B)(4) THAT THE "INLINE SUCTION CATHETER BROKE OFF IN THE PATIENT'S ENDOTRACHEAL TUBE [ETT], PRESENTING AN AIRWAY EMERGENCY. THE PIECE OF SUCTION TUBE THAT IS INSERTED INTO THE ETT IS WHAT BROKE, IT BROKE OFF INSIDE THE ETT. WE WERE ABLE TO RESOLVE THE ISSUE WITH NO ILL EFFECT TO THE PATIENT, WHO WAS ABLE TO BREATHE ON HIS OWN DURING THE EVENT. HOWEVER, DURING THIS EVENT THE PATIENT WAS DISCONNECTED FROM THE VENTILATOR AND WE DID NOT HAVE A WAY TO BAG HIM. THE SITUATION WAS RESOLVED WITHOUT HARM TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12318412 ↗