Ballard* Closed Suction System 98381Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00609038983813), received between Jul 15, 2020 and Jul 15, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Component Missing” (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.

• InjuryJul 15, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE "NON-RETURN VALVE" [IRRIGATION PORT COVER] WAS MISSING FROM THE DEVICE. PATIENT DESATURATED TO 95% AFTER FIVE MINUTES. THE DEVICE WAS REPLACED ALLOWING THE NORMALIZATION OF THE OXYGEN SATURATION. ADDITIONAL INFORMATION RECEIVED 29-JUN-2020 INDICATED "THE NURSE QUICKLY NOTICE[D] THE DYSFUNCTION, SO THERE WAS NO HARMFUL CONSEQUENCE FOR THE PATIENT."

  Patient problems: Low Oxygen Saturation

  MAUDE report 10276027 ↗