Salem Sump 8888266130 (UDI 10884521004719)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521004719), received between May 9, 2019 and Mar 12, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2025Break; Separation Failure; Break; Separation Failure

  THE CUSTOMER REPORTED THE PATIENT ARRIVED AT MEDICAL SURGERY UNIT WITH NG [NASO-GASTRIC TUBE] CAPPED WITH VENTILATION CAP FROM ED [EMERGENCY DEPARTMENT]. RN [REGISTERED NURSE] WENT TO REMOVE VENT CAP/PLUG TO HOOK PATIENT UP TO SUCTION, AND NG PLUG WAS STUCK AND WOULD NOT COME OUT. BOTH SIDES INSERTED WERE STUCK (BLUE AND WHITE) THE BLUE PLUG WAS IN THE BLUE TUBE, AND THE WHITE PLUG WAS IN THE CLEAR MAIN PORT. RN TRIED TO REMOVE, AND THE BLUE END SNAPPED AND BROKE IN THE TUBE. SECOND RN ATTEMPTED TO REMOVE AND COULD NOT. MANAGER BROUGHT IN AND THEY TRIED TO REMOVE WITH KELLY CLAMP AND WERE UNSUCCESSFUL. THEY CUT THE TUBING BELOW BOTH CAPS TO STILL UTILIZE THE PRODUCT, SO THEY DIDN'T HAVE TO REMOVE THE ITEM FROM THE PATIENT AND REPLACE. THE PATIENT DID STATE IF THE PRODUCT WAS REMOVED, SHE DID NOT WANT IT PLACED BACK AGAIN BECAUSE THE INSERTION IS NOT COMFORTABLE TO HER. OUTWEIGHED THE RISK VS BENEFITS AND FOUND NO RISK IN CUTTING THE TUBING BELOW THE STUCK CAPS. THEY WERE ABLE TO RE-HOOK UP SUCTION AND RECAP THE BLUE PORT WITH A NEW VENT CAP AFTER REMOVING THE STUCK CAPS. SUCTION WAS SUCCESSFULLY RESTARTED, AND PATIENT CARE WAS BACK TO NORMAL. THIS PRODUCT IS FAILING AND IS NOT USER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586077 ↗
• MalfunctionNov 17, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THERE WAS AN ISSUE WITH ONE OF THE NASOGASTRIC (NG) TUBES THAT WAS IN USE ON A PATIENT. AFTER BEING PUT INTO USE IT WAS FOUND TO BE CRACKED AND LED TO COMPLICATIONS. THE STAFF BELIEVES THAT THE PATIENT MAY HAVE JUST BIT/CHEWED AT SOME POINT. NONE OF THE OTHER UNITS CHECKED HAD ANY ISSUES. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT A CRACK (A SMALL SLIT) WAS FOUND IN THE TUBE APPROXIMATELY AT THE MEASUREMENT OF 65 AND THERE WAS NO DETACHMENT OBSERVED. THEY WERE NOT SURE IF THE TUBE WAS CRACKED DUE TO PATIENT BIT/CHEWED THE TUBE. DUE TO THE CRACK, SLOW TRICKLE OF LEAKING OF THE TUBE FEEDING WAS OBSERVED INTO THE MOUTH. THUS, SUCTIONING OUT OF THE MOUTH SECRETIONS THAT LEAD TO STOPPING THE TUBE FEEDING DUE TO WHAT WAS PERCEIVED TO BE INTOLERANCE. THE TUBE WAS REMOVED AND REPLACED WITH ANOTHER TUBE. PER MEDICAL STAFF, THEY WERE UNABLE TO ASSESS THE DETAILS OF MEDICAL INTERVENTION/TREATMENT PROVIDED TO THE PATIENT INVOLVED.

  Patient problems: Insufficient Information

  MAUDE report 15815159 ↗
• MalfunctionMar 18, 2022Material Twisted/Bent; Material Twisted/Bent

  CUSTOMER REPORTS: AFTER INSERTING THE TUBE INTO THE PATIENT THE NURSE NOTICED THAT IT WAS NOT PLACED PROPERLY. WHEN THEY TRIED TO REMOVE THE TUBE THEY WERE UNABLE TO BECAUSE IT WAS STUCK AND INFLICTING PAIN ON THE PATIENT. THEY CUT THE TUBE AND REMOVED SOME THROUGH THE MOUTH AND THE REST THROUGH THE NOSE. THE TUBE SOMEHOW KNOTTED ITSELF WHILE IT WAS BEING INSERTED.

  Patient problems: Pain

  MAUDE report 13803950 ↗
• MalfunctionOct 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTS: THE ANTI-REFLUX VALVE ON PATIENT ORAL GASTRIC TUBE. THE WHITE END CONNECTED TO ORAL GASTRIC TUBE TO CLAMP OFF SYSTEM DURING TRANSPORT TO MRI. ON RETURN FROM MRI, WHEN ATTEMPTING TO DISCONNECT WHITE END FROM ORAL GASTRIC DRAIN END WHITE PIECE BROKE OFF FROM VALVE SYSTEM AND REMAINED IN ORAL GASTRIC TUBE. COULD NOT REMOVE WHITE END DESPITE ATTEMPT TO PRY OUT OF TUBE. ORAL GASTRIC TUBE REMOVED. NEW NASOGASTRIC TUBE INSERTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12632007 ↗
• MalfunctionMar 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PATIENT HAD AN OGT IN PLACE WITH TUBE FEEDS INFUSING WHEN THEY NOTICED THAT THE TUBE FEEDS WERE LEAKING IN THE BED. UPON LOOKING FOR A SOURCE OF THE LEAK, THEY FOUND THAT THERE WAS A SMALL HOLE IN THE OG TUBING LOCATED AT THE BIFURCATION OF THE SMALL BLUE VENT TUBING WHERE IT CONNECTS TO THE TUBE ITSELF. THEY TAPED OVER THE BIFURCATION HOPING TO STOP THE LEAK BEFORE ULTIMATELY HAVING TO REPLACE THE ENTIRE OG TUBE. HOWEVER, THE NEW OG TUBE THAT WAS PLACED WAS ALSO LEAKING FROM THE EXACT SAME LOCATION. THIS WAS CAUSING THE PATIENT TO NOT RECEIVE ALL OF THE ORDERED TUBE FEEDS AND WATER FLUSHES AS THEY LEAK OUT, SOAKING THE PATIENT'S GOWN, SHEETS, ETC. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Feeding Problem

  MAUDE report 11562491 ↗
• MalfunctionMay 29, 2020Difficult to Remove

  AN EMERGENCY DEPARTMENT PATIENT HAD AN NG TUBE PLACED. THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL. THE ED NURSE USED THE ANTI-REFLUX VALVE AS A STOPPER IN THE TUBE DURING TRANSPORT. WHEN THE PATIENT ARRIVED IN THE INPATIENT AREA, THE NURSE WAS UNABLE TO REMOVE THE ANTI-REFLUX VALVE FROM THE NG TUBE IN ORDER TO CONNECT IT TO INTERMITTENT SUCTION PER PROVIDER ORDERS. THE TUBE HAD TO BE CUT IN ORDER TO REMOVE THE VALVE. WE ARE SUGGESTING AN ENGINEERING CHANGE MAY BE HELPFUL IN ORDER FOR THERE TO BE A WAY TO HAVE A SAFE STOPPER IN THE TUBE ITSELF INSTEAD OF USING THE VALVE - OR POSSIBLY MODIFICATION OF THE VALVE SO IT CAN SAFETY BE USED AS A STOPPER FOR DURING PATIENT TRANSPORT AND/OR WHEN NOT ATTACHED TO SUCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10100712 ↗
• MalfunctionMay 13, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THERE WAS A CUT OR INDENT ON THE ENTRY SITE OF THE CONNECTION CAUSING THE FEED TO LEAK. THE TUBE WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. PRIOR TO INSERTION OF THE SECOND TUBE, THE HEALTH CARE PROVIDER NOTICED THIS SAME ISSUE ON TWO OTHER TUBES IN THE SAME SPOT ON THE DEVICE AND DID NOT USE THEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8603413 ↗
• MalfunctionMay 9, 2019Break

  STAFF NOTED THAT THE DEVICE IS BROKEN IN THE BAG. NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8595060 ↗