Salem Sump 8888264929 (UDI 10884521007673)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521007673), received between Sep 20, 2017 and Sep 20, 2017 — classified as 1 malfunction.

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

• MalfunctionSep 20, 2017Kinked; Kinked

  CUSTOMER REPORTS THAT THE PATIENT NEEDED AN ORAL GASTRIC TUBE (OGT) PLACED, NOT MANUFACTURED BY COVIDIEN. THIS WAS APPROXIMATELY THE 3RD OGT HE HAS NEEDED DURING HIS CURRENT HOSPITAL STAY. THE NURSE WAS UNABLE TO GET AN OGT PLACED DURING DAY SHIFT AS IT KEPT COILING IN HIS MOUTH. THE NURSE OBTAINED A 12 FRENCH COVIDIEN SALEM SUMP DUAL LUMEN STOMACH TUBE BUT WAS ALSO UNSUCCESSFUL FOR THE SAME REASON. THE NIGHT NURSE WAS THEN ABLE TO PLACE THE OGT EASILY WITHOUT ANY ISSUE OR RESISTANCE AND OBTAINED AN X-RAY TO CONFIRM PLACEMENT. THE X-RAY SHOWED THAT THE OGT WAS IN THE PATIENT'S LUNG AND WAS REMOVED WITHOUT INCIDENT APPEARING INTACT UPON REMOVAL. THE PATIENT REQUIRED A BRONCHOSCOPY DUE TO HIS ILLNESS AND DISEASE PROCESS. DURING THE BRONCHOSCOPY, THE PHYSICIAN FOUND A 4CM PIECE OF AN OGT IN PATIENT'S LUNG. IT WAS REMOVED WITHOUT INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6878651 ↗