Salem Sump 7771810E (UDI 10884521582743)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10884521582743), received between Feb 17, 2020 and Oct 8, 2024 — classified as 3 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2024Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT HE TESTED THE DEVICE BY HAND TO SEE HOW EASILY THE TIP CAN COME OFF AND IT CAME OFF BUT NOT AS EASILY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397399 ↗
• MalfunctionMay 23, 2023Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THERE HAVE BEEN SOME ISSUES FROM THEIR CLINICAL TEAM WHEN USING THE ENFIT SALEM SUMP TUBE. THEY DIDN¿T HAVE THE PROPER SYRINGES AND REFUSED TO PURCHASE THEM FOR FLUSHING THE SALEM SUMP WHEN NEEDED, SO THEREFORE THE DEVICE BECAME CLOGGED AND PROBLEMATIC IN THE OR WHEN THE DEVICE WAS CLOGGED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16985835 ↗
• MalfunctionNov 16, 2022Suction Problem; Suction Problem

  THE CUSTOMER REPORTED NURSING HOOKED UP A SALEM SUMP WITH MULTIFUNCTION PORT TO WALL SUCTION AND NO SUCTION OCCURRED. PATIENT ASPIRATED. ADDITIONAL INFORMATION RECEIVED STATED: PLACEMENT OF THE TUBE WAS VERIFIED ON AN INTUBATED PATIENT. TUBE FEEDS WERE BEING FED THROUGH THIS TUBE AT A RATE OF 30ML/HR. THEY CHECKED RESIDUALS AT 0800. THE RESIDUALS WERE 25ML. AT 0900 WHEN THEY LAID THE PATIENT FLAT TO TURN (TUBE FEEDS WERE TURNED OFF AT THIS TIME), THE PATIENT BEGAN TO VOMIT AROUND THE NG/OG TUBE. THEY PROMPTLY SAT THE PATIENT UP, GRABBED A YANKUER AND PUT THE NG/OG TO SUCTION WHILE SUCTIONING THE MOUTH AND THE PATIENT'S AIRWAY WITH THE INLINE SUCTION. THE NG/OG WOULD NOT REMOVE ANY CONTENTS FROM THE THE STOMACH. IT WOULD NOT SUMP CORRECTLY. THE WALL SUCTION WAS WORKING CORRECTLY, THEY TRIED INTERMITTENT SUCTIONING AND IT WAS BETTER BUT IT WOULDN'T COME DOWN THE TUBE. WALL SUCTION WAS SET AT 80-120. THEY TRIED HIGHER AND LOWER. THE CANNISTER WAS INTACT AS WELL. THEY ALSO ASPIRATED AND FLUSHED THE NG/OG WITH AIR BUT IT WOULD NOT SUMP. THE PATIENT VOMITED AGAIN AROUND THE TUBE. THE CUSTOMER ORIGINALLY STATED THE PATIENT ASPIRATED BUT IN THE ADDITIONAL INFORMATION RECEIVED FROM THE CUST

  Patient problems: Vomiting

  MAUDE report 15804217 ↗
• MalfunctionJun 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE MULTI FUNCTIONAL PORT LEAKED AT CLEAR BLUE PLASTIC END. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11991219 ↗
• MalfunctionMay 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE ICU MANAGER WAS MOVING A PATIENT AND THE PURPLE PORT BROKE OFF CAUSING THE SYRINGE TO FALL OFF IN THE BED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885552 ↗
• MalfunctionMay 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER STATES FLUID (BILE) LEAKED INTO CHAMBER OF THE MULTIFUNCTIONAL PORT OF THE SALEM SUMP.

  Patient problems: Insufficient Information

  MAUDE report 11850364 ↗
• MalfunctionMay 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER STATES FLUID LEAKED INTO THE CHAMBER OF THE MULTIFUNCTIONAL PORT OF THE SALEM SUMP.

  Patient problems: Insufficient Information

  MAUDE report 11798369 ↗
• MalfunctionDec 15, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THE TUBE WAS CLOGGED AND WHEN IT WAS REMOVED, THE TIP WAS NOTED TO BE BLACKENED AND STIFF. THIS TUBE WAS REPLACED WITH A DOBHOFF. IT WAS PLACED ON 11/23 AND REMOVED 11/29. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11011913 ↗
• MalfunctionDec 13, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE MULTIFUNCTION PORT WAS LEAKING.

  Patient problems: Insufficient Information

  MAUDE report 10998294 ↗
• MalfunctionDec 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE MULTIFUNCTIONAL PORT WAS LEAKING AT THE ARV PORT. IT IS UNKNOWN IF IT WAS GASTRIC FLUID OR TUBE FEED THAT WAS LEAKING. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10985837 ↗
• MalfunctionNov 25, 2020Suction Problem; Suction Problem

  THE CUSTOMER REPORTED: AN NG WAS INSERTED INTO A PATIENT AND A 300 ML OUTPUT OCCURRED RIGHT AWAY BUT THEN IT STOPPED WORKING. THE MULTIFUNCTION PORT CONNECTION WAS CHANGED AND IT BEGAN TO WORK AGAIN BUT SLUGGISHLY. IT HAS SINCE STOPPED WORKING AND THE PATIENT WOKE UP FROM SLEEP LAST NIGHT STILL VERY DISTENDED AND UNCOMFORTABLE.

  Patient problems: Abdominal Distention

  MAUDE report 10906664 ↗
• MalfunctionNov 9, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THE NASOGASTRIC TUBE (NGT) WAS IN PLACE (B)(6) 2020 THROUGH (B)(6) 2020 WHEN THE TUBE APPEARED CLOGGED SO MEDS WERE INSTILLED TO HELP DISSOLVE THE OCCLUDED TUBE. THE NURSE INFORMED IT DID NOT WORK AND SHE REMOVED THE TUBE TO FIND THE END OF THE TUBE WAS BLACK ON THE INSIDE AND CLOGGED. THERE WAS NO HARM TO THE PATIENT AND NO INTERVENTION NEEDED. THE PATIENT HAD A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACED WHICH WAS DISCUSSED IN THE PLAN OF CARE EARLIER IN HER HOSPITAL STAY PRIOR TO THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10808511 ↗
• MalfunctionOct 22, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER STATED THAT THE RN REPORTED THAT THE ENFIT CONNECTOR LEAKED AROUND EITHER THE TUBE OR THE LUER CONNECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10720923 ↗
• MalfunctionOct 22, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PORT WAS LEAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10720865 ↗
• MalfunctionOct 15, 2020Suction Problem; Detachment of Device or Device Component; Suction Problem; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE PATIENT'S NG WAS NOT SUCTIONING. IT IS CURRENTLY WORKING, BUT PER THE NURSE, NOT AS IT SHOULD. ALSO, WHEN CHANGING THE MULTIPORT DEVICE, THE CONNECTION SITE BROKE. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT THERE WAS AN INJURY ASSOCIATED WITH THIS EVENT. THE PATIENT REQUIRED SICU ADMISSION, INTUBATION, ANTIBIOTICS, AND TRACHEOSTOMY FOR PROLONGED INTUBATION. THE NURSE FURTHER STATED THAT SHE FELT THAT THE SUCTIONING WAS NOT AS STRONG AS IT SHOULD HAVE BEEN, IT WAS LACKLUSTER OR MEDIOCRE.

  Patient problems: No Code Available

  MAUDE report 10687211 ↗
• InjuryOct 7, 2020Suction Problem; Detachment of Device or Device Component; Suction Problem; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE PATIENT'S NG WAS NOT SUCTIONING. IT IS CURRENTLY WORKING, BUT PER THE NURSE, NOT AS IT SHOULD. ALSO, WHEN CHANGING THE MULTIPORT DEVICE, THE CONNECTION SITE BROKE. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT THERE WAS AN INJURY ASSOCIATED WITH THIS EVENT. THE PATIENT REQUIRED SICU ADMISSION, INTUBATION, AND ANTIBIOTICS. THE NURSE FURTHER STATED THAT SHE FELT THAT THE SUCTIONING WAS NOT AS STRONG AS IT SHOULD HAVE BEEN, IT WAS LACKLUSTER OR MEDIOCRE.

  Patient problems: No Code Available; No Information

  MAUDE report 10645397 ↗
• MalfunctionOct 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE TRANSPLANT UNIT SAW AN ISSUE WITH LEAKING OF THE TUBING. ON ASSESSMENT, NO CRACK OR TUBE INTEGRITY ISSUES WERE NOTED. AIR WAS INSTILLED INTO THE AIR PORT AND THEN THE MULTIFUNCTION PORT WAS CHANGED. THE TUBE WAS REMOVED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10628048 ↗
• MalfunctionOct 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE TRANSPLANT UNIT SAW AN ISSUE WITH CONTRAST SOLUTION LEAKING OUT AND SUBSEQUENT LEAKING OF THE TUBING. ON ASSESSMENT, NO CRACK OR TUBE INTEGRITY ISSUES WERE NOTED. AIR WAS INSTILLED INTO THE AIR PORT AND THEN THE MULTIFUNCTION PORT WAS CHANGED. THE TUBE WAS REMOVED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10627971 ↗
• MalfunctionOct 5, 2020Decrease in Suction; Fluid/Blood Leak; Decrease in Suction; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE PATIENT¿S MULTIFUNCTIONAL PORT WAS LEAKING. IT WAS REPLACED AND SEEMED TO DO BETTER WITH SUCTIONING, BUT HAD TO BE MANIPULATED IN THE BEGINNING BEFORE IT STARTED WORKING WELL. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10627929 ↗
• MalfunctionOct 5, 2020Decrease in Suction; Decrease in Suction

  THE CUSTOMER REPORTED THE PATIENT¿S MULTIFUNCTIONAL PORT WAS INTACT, BUT WASN¿T SUCTIONING VIGOROUSLY. THE PORT WAS REPLACED AND WAS STILL HAVING ISSUES WITH SUCTION AFTER UTILIZING THE AIR REFLUX VALVE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10627889 ↗
• MalfunctionSep 15, 2020Decrease in Suction; Decrease in Suction

  THE CUSTOMER REPORTED THE NURSE PRACTITIONER STATED THE PATIENT¿S NG SUMP HAD NOT BEEN FUNCTIONING PROPERLY; THERE WAS LACK OF SUCTION/DECOMPRESSION. THE PATIENT VOMITED BUT DID NOT REQUIRE ANY MEDICAL INTERVENTION OTHER THAN HAVING THE DEVICE REPLACED.

  Patient problems: Vomiting

  MAUDE report 10535397 ↗
• InjurySep 15, 2020Decrease in Suction; Decrease in Suction

  THE CUSTOMER REPORTED THE NURSE PRACTITIONER STATED THE PATIENT¿S NG SUMP HAS NOT BEEN FUNCTIONING PROPERLY; THERE WAS LACK OF SUCTION/DECOMPRESSION. THE PATIENT VOMITED AND ASPIRATED, THEN NEEDED TO BE INTUBATED.

  Patient problems: Aspiration/Inhalation; Vomiting

  MAUDE report 10535089 ↗
• InjurySep 15, 2020Decrease in Suction; Decrease in Suction

  THE CUSTOMER REPORTED THE NURSE PRACTITIONER STATED THE PATIENT¿S NG SUMP HAS NOT BEEN FUNCTIONING PROPERLY; THERE WAS LACK OF SUCTION/DECOMPRESSION. THE PATIENT VOMITED AND ASPIRATED, THEN NEEDED TO BE INTUBATED.

  Patient problems: Aspiration/Inhalation; Vomiting

  MAUDE report 10534989 ↗
• MalfunctionSep 4, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THE PORT WAS LEAKING AT THE JUNCTION OF THE MULTI-FUNCTION PORT AND THE TUBE CONNECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10495071 ↗
• MalfunctionSep 4, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT: THE CNS IN THE NCCU SAID SHE HAS RECEIVED MULTIPLE COMPLAINTS OF LEAKING AT THE CONNECTION OF THE MULTI-FUNCTION PORT AND THE TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10494983 ↗