Salem Sump 8888264911 (UDI 10884521007666)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521007666), received between Nov 7, 2019 and May 21, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2020Crack; Obstruction of Flow; Crack; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE NURSE IDENTIFIED THE RUPTURE OF THE NG TUBE WHEN THEY TOOK IT FOR CLEANING AND FLUSHING. THEY ARE UNAWARE OF HOW THIS HAPPENED AND REPLACED IT WITH A NEW PIECE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE BREAKAGE WAS AT THE DISTAL END TIP OF THE NG TUBE. ADDITIONAL INFORMATION WAS AGAIN PROVIDED ON JUNE 11, 2020 STATING THAT THE TUBE WAS NOT IN PLACE IN THE PATIENT WHEN THE CLEANING AND FLUSHING OF THE TUBE WAS DONE. THE RUPTURE WAS SUSPECTED AND DISCOVERED WHEN THE CATHETER WAS REMOVED FROM THE PATIENT FOR FLUSHING TO CLEAR A BLOCKAGE. THEY TRIED TO FLUSH WITH 3MLS OF WATER HOURLY WHILE SITU ORALLY BUT IS WAS NOT EFFECTIVE TO CLEAR THE BLOCKAGE. THEY NEEDED TO REMOVE THE CATHETER FROM THE PATIENT'S ORAL CAVITY TO PERFORM MANUAL FLUSHING AT LEAST 3-4 TIMES DAILY TO CLEAR THE BLOCKAGE. THERE WAS NO DIFFICULTY EXPERIENCED WITH THE TUBE INSERTION. THE PATIENT IS A NEONATE PATIENT. THERE HAVE BEEN NO COMPLAINTS OF DISCOMFORT AND NO ADVERSE EVENTS ASSOCIATED WITH THIS ISSUE. THE PATIENT CURRENTLY STILL REQUIRES THE PLACEMENT OF THE CATHETER TO CONTINUE SUCTIONING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10079002 ↗
• MalfunctionNov 7, 2019Break; Break

  THE CUSTOMER REPORTED THE TIP OF THE SALEM SUMP TUBE WAS FOUND BROKEN DURING DAILY CHECKS OF THE TUBE. THE TUBE IS USED TO REMOVE ACCUMULATION OF SALIVA IN THE ESOPHAGUS USING A SUCTION UNIT, WITH 40 MMHG PRESSURE. THE CUSTOMER FURTHER CLARIFIED THE TIP THEY ARE REFERRING TO IS AT THE END WHERE THE HOLES ARE. THE BREAKAGE HAPPENED AT ONE OF THE HOLES BUT IS STILL ATTACHED TO THE TUBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9290404 ↗