Salem Sump 8888266197 (UDI 10884521007628)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521007628), received between Oct 3, 2019 and Aug 15, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE SALEM SUMP ANTI-REFLUX VALVE SNAPPED IN HALF WHILE IN PATIENTS' NG TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22818193 ↗
• MalfunctionAug 14, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE PATIENT HAS NASOGASTRIC TUBE TO LOW-INTERMITTENT SUCTION. PATIENT'S NG TUBE WAS CLAMPED FOLLOWING LIQUID PO TYLENOL ADMINISTRATION. NG TUBE WAS CLAMPED USING "SALEM SUMP ANTI-REFLUX VALVE" PIECE. WHEN DISCONNECTING PIECE FROM NG TUBE TO RETURN TO SUCTION, WHITE PART OF "SALEM SUMP ANTI-REFLUX VALVE" BROKE AND BECAME LODGED INTO NG TUBE, COMPLETELY BLOCKING TUBE. PIECE WAS ABLE TO BE REMOVED AFTER 15MIN OF ATTEMPTING TO DISLODGE PIECE. NG RETURNED TO LIS WITHOUT ANY FURTHER ISSUE FOLLOWING REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812398 ↗
• MalfunctionMay 29, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE WRITER WENT TO UNCLAMP THE SALEM SUMP NASOGASTRIC TUBE (NG) AS IT HAD BEEN 30 MINUTES SINCE THE ADMINISTRATION OF MEDICATION. PER CUSTOMER, THE ANTI-REFLUX VALVE BROKE OFF INSIDE THE DISTAL END OF THE SALEM SUMP. THE WRITER AND ANOTHER NURSE ATTEMPTED TO REMOVE IT BY HAND AND WITH A CLAMP, BUT THE BROKEN END KEPT BREAKING OFF SMALL PIECES OF THE PLASTIC. THE WRITER WAS ABLE TO CUT THE DISTAL PORTION OFF, PRESERVING THE TUBE AND ITS FUNCTION AND RECONNECT THE PATIENT TO LOW CONTINUOUS SUCTION. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107640 ↗
• MalfunctionJan 8, 2025Break; Break

  THE CUSTOMER REPORTED WHEN USING THE ANTI-REFLUX VALVE WITH THE NG TUBE, IT IS BREAKING WHEN THEY ATTEMPT TO REMOVE IT FROM THE TUBE. THEY HAVE HAD THIS HAPPEN MULTIPLE TIMES NOW SO THEY ARE THINKING IT MAY BE A PRODUCT ISSUE INSTEAD OF A USER/FLUKE THING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105995 ↗
• MalfunctionMay 26, 2024Break; Break

  THE CUSTOMER REPORTED THAT THE ARV BROKE WHEN TRYING TO REMOVE IT FROM THE SALEM SUMP - THE PART THAT WAS IN THE SUMP STAYED IN, AND THE PART OUT, BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398947 ↗
• MalfunctionApr 29, 2024Break; Break

  THE CUSTOMER REPORTED THE BLUE END BROKE OFF FOR SEEMINGLY NO REASON PER STAFF NURSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200848 ↗
• MalfunctionApr 29, 2024Break; Break

  THE CUSTOMER REPORTED THE BLUE END BROKE OFF THE ARV FOR SEEMINGLY NO REASON (PER THE STAFF NURSE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200778 ↗
• MalfunctionFeb 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER REPORTS: THE SALEM SUMP CONNECTOR BETWEEN THE NASOGASTRIC TUBE AND THE SUCTION TUBING BROKE IN HALF WHEN THE BEDSIDE NURSE ATTEMPTED TO RECONNECT THE SUCTION AFTER IT HAD BEEN CLAMPED OFF. SHE PULLED THE PIECE OUT OF THE END OF THE NASOGASTRIC TUBE AND IT BROKE LEAVING THE BLUE HALF OF THE DEVICE LODGED INSIDE THE NASAL GASTRIC TUBE (NGT). STAFF WERE ABLE TO REMOVE THE CONNECTOR FROM THE TUBE. AFTERWARD, WERE ABLE TO RESUME SUCTION. IMPACT OF INCIDENT: THE PATIENT WAS FRUSTRATED AS WE WERE UNABLE TO INITIATE THE SUCTION FOR SOME TIME UNTIL IT WAS PROBLEM SOLVED.

  Patient problems: Discomfort

  MAUDE report 18650819 ↗
• MalfunctionOct 3, 2019Disconnection; Inadequate User Interface; Disconnection; Inadequate User Interface

  THE CUSTOMER REPORTED THAT THE VALVES WERE BROKEN IN TWO WHEN THE STAFF TRIED TO REMOVE THEM FROM THE PATIENT¿S TUBE. WHILE THE PATIENT WAS ATTACHED TO SUCTION, THE VALVE PREVENTS BACK FLOW OF FLUID THROUGH THE AIR VENT OF THE TUBE; THE BLUE END OF THE VALVES SITS ON THE BLUE AIR VENT OF THE TUBE. WHEN SUCTION WAS NOT IN USE, THE VALVE WAS USED TO ¿CAP¿ THE TUBE BY INSERTING THE WHITE END OF THE VALVE INTO THE DRAINAGE LUMEN TUBE. IT¿S WHEN THE STAFF TRIED TO PULL THE VALVE OUT OF THE DRAINAGE LUMEN TO RECONNECT THE PATIENT TO SUCTION THAT THE VALVE SPLITS IN TWO LEAVING THE WHITE PORTION PLUGGED INTO THE DRAINING LUMEN. ADDITIONAL INFORMATION RECEIVED ON 10/01/2019 CONFIRMED THAT THE ANTI REFLUX VALVE FAILED TO VENT THE STOMACH HOWEVER THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9152804 ↗