Salem Sump 8888266148 (UDI 10884521004726)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521004726), received between Mar 13, 2018 and Mar 28, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2024Break; Break

  PER CUSTOMER, THE INCIDENT IN QUESTION INVOLVED A 78-YEAR-OLD PATIENT WHO HAD AN NG (NASOGASTRIC) TUBE PLACED FOR MEDICAL REASONS. A SMALL BOWEL FOLLOW-THROUGH (SBFT) TEST WAS SCHEDULED FOR THE MORNING, REQUIRING THE NG TUBE TO BE TEMPORARILY CLAMPED. TO ACHIEVE THIS, THE BLUE/WHITE FILTER WAS INSERTED INTO THE OPEN END OF THE NG TUBE AS A PLUG. HOWEVER, WHEN IT WAS TIME TO RECONNECT THE PATIENT TO WALL SUCTION, THE FILTER BROKE IN HALF AND BECAME LODGED INSIDE THE NG TUBE. EFFORTS WERE MADE BY BOTH A REGISTERED NURSE (RN) AND THE CHARGE NURSE TO REMOVE THE STUCK FILTER, BUT THESE ATTEMPTS WERE UNSUCCESSFUL. MULTIPLE TOOLS WERE EMPLOYED IN THE ATTEMPT TO DISLODGE THE FILTER, BUT THEY PROVED INEFFECTIVE. THE CUSTOMER FURTHER EXPLAINED THAT THE BLUE PART WAS SEATED IN THE MAIN LUMEN. THIS IS WHAT THE PRODUCT DESCRIPTION STATES TO DO TO PLUG THE SYSTEM WHEN NOT IN USE. WHERE THE VENT ATTACHES TO THE BLUE PART IS WHERE THE ITEM SNAPPED OFF COMPLETELY. WHEN ATTEMPTING TO REMOVE IT, ENOUGH FORCE WAS USED TO TRY AND PRY THE ITEM OUT. THE CUSTOMER WAS TOLD THE NURSE WAS TRYING TO TWIST AND TURN IT OUT AS WELL WITH NO SUCCESS. IT WAS STUCK INITIALLY WHEN REMOVAL WAS ATTEMPTED. SINCE THE NG

  Patient problems: Aspiration/Inhalation; Discomfort; Epistaxis

  MAUDE report 18998195 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT WHILE THE ITEM WAS BEING INSERTED INTO THE PATIENT'S ESOPHAGUS, A PERFORATION OCCURRED CAUSING INJURY TO THE PATIENT. THE CUSTOMER STATED THAT THEY CANNOT BE SURE IF THE PERFORATION WAS CAUSED DUE TO A DEFECT ON THE ITEM ITSELF OR IF IT WAS AN ERROR IN EXECUTING THE PROCEDURE USING THE PRODUCT. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2023 STATED THAT THE PERFORATION WAS ON THE ESOPHAGUS. AS A RESULT, THE PATIENT REQUIRED AN EMERGENT EXPLORATION OF NECK REPAIR OF ESOPHAGEAL PERFORATION. NO ADDITIONAL INJURY OR INTERVENTION WAS REQUIRED. THE PATIENT'S CURRENT STATUS IS STABLE. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2023 STATED THAT THE PATIENT ORIGINALLY WENT TO THE HOSPITAL FOR A D&C. THE INITIAL REASON FOR THE SALEM SUMP PLACEMENT WAS DUE TO GENERAL ANESTHESIA. THE SALEM SUMP WAS PLACED IN THE OR BY A MD AND CRNA.

  Patient problems: Perforation of Esophagus

  MAUDE report 17393963 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT WHILE THE ITEM WAS BEING INSERTED INTO THE PATIENT'S ESOPHAGUS, A PERFORATION OCCURRED CAUSING INJURY TO THE PATIENT. THE CUSTOMER STATED THAT THEY CANNOT BE SURE IF THE PERFORATION WAS CAUSED DUE TO AN ISSUE WITH THE ITEM ITSELF OR IF IT WAS AN ERROR IN EXECUTING THE PROCEDURE USING THE PRODUCT. ADDITIONAL INFORMATION PROVIDED ON (B)(6), 2023 STATED THAT THE PERFORATION WAS ON THE ESOPHAGUS. AS A RESULT, THE PATIENT REQUIRED SURGERY, A LEFT THORACOTOMY WITH TOTAL PULMONARY DECORTICATION AND WASHOUT. ADDITIONALLY, THE PATIENT HAD SEPTIC SHOCK SECONDARY TO MEDIASTINITIS AS A RESULT OF THIS INCIDENT. THE PATIENT'S CURRENT STATUS IS STABLE. ADDITIONAL INFORMATION PROVIDED ON (B)(6), 2023 STATED THAT THE PATIENT ORIGINALLY WENT TO THE HOSPITAL FOR ROBOTIC ASSISTED COLOSTOMY TAKEDOWN. THE INITIAL REASON FOR THE SALEM SUMP PLACEMENT WAS DUE TO GENERAL ANESTHESIA. THE SALEM SUMP WAS PLACED IN THE OR BY A MD AND CRNA.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Perforation of Esophagus; Septic Shock

  MAUDE report 17393962 ↗
• MalfunctionAug 22, 2019Break; Break

  THE CUSTOMER REPORTS THAT THE VERY TIP OF THE DEVICE IS ALMOST DISCONNECTED AND JAGGED CAUSING PAIN TO THE PATIENT WHEN THEY PULL IT OUT. THE TUBE WAS TO BE USED FOR SUCTION. FURTHER CONTINUOUS OBSERVATION WAS DONE FOR THE PATIENT. THE HEALTH CARE PROVIDER DECIDED NOT TO INSERT THE TUBE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Pain

  MAUDE report 8920524 ↗
• MalfunctionMar 13, 2018Material Separation

  THE SALEM PUMP VALVE SEPARATED WHILE IN USE. NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7333618 ↗