Salem Sump 7771610ERecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521582736), received between Sep 17, 2019 and Oct 8, 2024 — classified as 1 death, 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 18 most recent of 18 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 20397268 ↗
• MalfunctionSep 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER STATED THAT THE CLEAR BLUE PART OF THE MULTI-FUNCTIONAL PORT OF THE SALEM SUMP BECAME UNGLUED AND SEPARATED. THERE WAS NO HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE ARV VALVE WAS NOT DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15405671 ↗
• DeathMay 6, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE CUSTOMER REPORTED USING DEVICE 7771610E; CARDINAL SALEM SUMP DUAL LUMEN STOMACH TUBE, KANGAROO MULTIFUNCTION PORT W/ENFIT EQUIPPED DEVICE IS MANDATORY FOR USE AS AN NG TUBE IN (B)(6) UNDER AB444, EXCEPT IN EMERGENCIES. THE PATIENT WAS SEVERELY INJURED IN A MOTOR VEHICLE COLLISION ON (B)(6) 2022, AND INITIALLY WENT FROM TRAUMA BAY TO THE OPERATING ROOM FOR LAPAROTOMY AND SPLENECTOMY AND OTHER PROCEDURES. HE WAS ADMITTED TO THE ICU WITH TRAUMATIC BRAIN INJURY AND OTHER INJURIES, ON THE VENTILATOR AND REQUIRED PLACEMENT OF THE NG TUBE SHOWN ABOVE. HE UNDERWENT FURTHER SURGICAL PROCEDURES ON (B)(6) 2022 AND REMAINED ON THE VENTILATOR. ON (B)(6) 2022 THE PATIENT BIT THROUGH THE PILOT LINE OF HIS ENDOTRACHEAL TUBE. A DECISION WAS MADE TO PERFORM A BRONCHOSCOPY AND EXCHANGE THE TUBE. PRIOR TO THE TUBE EXCHANGE, WITH A PATIENT STILL ON THE VENTILATOR, THE PATIENT WAS THOUGHT TO BE ON NG SUCTION VIA THE KANGAROO DEVICE. HOWEVER, DURING TUBE EXCHANGE, THE PATIENT HAD A LARGE AMOUNT OF EMESIS AND ASPIRATED GASTRIC CONTENTS INTO HIS AIRWAYS. THIS WAS CONFIRMED ON THE SUBSEQUENT BRONCHOSCOPY. CLOSE EXAMINATION OF THE KANGAROO DEVICE ON THE ENFIT SALEM SUMP TO REVEAL THAT THE SWITCH WAS IN T

  Patient problems: Adult Respiratory Distress Syndrome; Aspiration/Inhalation

  MAUDE report 14311576 ↗
• MalfunctionApr 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THEY HAVE BEEN SPLASHED WITH CONTENTS FROM THE MEDICATION PORT ON THE MULTI-FUNCTION CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196472 ↗
• MalfunctionApr 22, 2022Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THERE WERE MULTIPLE CONCERNS ESCALATED RELATED TO THE CLOGGING OF THE ENFIT NG TUBE. PER CUSTOMER, MOST RECENTLY IT CAUSED PATIENT¿S DISCOMFORT AND POTENTIAL HARM WITH CLOG CAUSING 1200 ML OF CONTENTS NOT BEING EXTRACTED. AS A STAFF WORK AROUND, AN ALTERNATE CONNECTOR FROM DIFFERENT/PREVIOUS PRODUCT WAS USED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT SPECIFIC CONCERN REPORTED WAS THAT THE CONTENTS FROM THE STOMACH WERE THICK/CHUNKY AND TUBE CONTINUED TO CLOG ALTHOUGH FLUSHING WAS OCCURRING. MULTI-FUNCTIONING CONNECTER WAS REMOVED AND REPLACED WITH A DIFFERENT (PREVIOUS) CONNECTION THAT ALLOWED THE CONTENTS TO DRAIN/EMPTY SO THE PATIENT COULD HAVE SYMPTOM RELIEF AND THE RESULT WAS THE 1200 ML OF CONTENT WAS EXTRACTED AFTER THE CONNECTOR WAS CHANGED. THEN THE CONNECTION PIECE WAS REPLACED BACK WITH THE MULTI-FUNCTION ONE. THERE WAS NO HARM JUST A CONCERN FOR PAIN/DISCOMFORT DUE TO CONTENTS NOT DRAINING APPROPRIATELY.

  Patient problems: Discomfort; Pain

  MAUDE report 14190125 ↗
• MalfunctionApr 5, 2022Suction Problem; Suction Problem

  THE CUSTOMER REPORTED, COVIDIEN SALEM SUMP TUBING IS USED IN THE OPERATING ROOM FOR GASTRIC SUCTION IN PATIENTS. ON SEVERAL OCCASIONS, THE VALVE USED FOR SUCTION HAS FAILED, LEAVING PATIENT SECRETIONS ON THE FACE AND/OR RETURNING TO THE PATIENTS STOMACH.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14013858 ↗
• MalfunctionFeb 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE DEVICE WAS LEAKING AT THE CONNECTION BETWEEN THE NG TUBING AND THE MULTIFUNCTION PORT CONNECTOR. WHEN THE CUSTOMER ASKED A LARGE GROUP OF STAFF, THEY STATED THEY HAVE SEEN THAT BUT SEEMS TO BE THAT SOMEONE PUT IT IN UPSIDE DOWN OR ANOTHER INSTANCE IT WAS NOT CLOSED CORRECTLY ON THE DIAL. PER ADDITIONAL INFORMATION RECEIVED, THEY WEREN'T PUSHING THE MULTI-FUNCTION PORT ALL THE WAY INTO THE TUBING ITSELF AND THEREFORE CAUSING THE LEAKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13608304 ↗
• MalfunctionAug 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  BENEFIS HEALTH SYSTEM'S ICU REPORTED THAT OUR SALEM SUMPS WITH MULTI-FUNCTION PORT WERE LEAKING AROUND THE ANTI-REFLUX VALVE AND IN THE SEAMS OF THE MULTIFUNCTION PORT WHERE THE TWO SIDES OF THE FRONT AND BACK COME TOGETHER. IT IS NOTICED THE MOST WHEN REFLUX IS SEEN COMING UP TOWARDS THE ARV AND A BUFFER OF AIR OR LIQUID USED TO PUSH IT PACK DOWN VIA A SYRINGE. LIQUID FILLS THE BLUE CAVITY AND LEAKS OUT THE SEAMS OF THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 12336727 ↗
• MalfunctionMay 21, 2021Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE SURGEON WAS CHECKING THE DEVICE FOR PATENCY USING AIR BOLUS AND DETERMINED IT WOULD NOT BOLUS AIR. ALL TROUBLESHOOTING WAS PERFORMED. AFTER TESTING WITH AND WITHOUT THE ATTACHED TO THE PORT, THE ISSUE SEEMED TO BE WITH THE PORT. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2021 STATED THAT DURING THE PROCEDURE THE SURGEON ASKED FOR MORE SUCTION BECAUSE HE WAS NOT ACHIEVING DESIRED RESULTS. IT WAS DETERMINED THAT THE DEVICE WAS FAULTY AND IT WAS REPLACED WITH A DIFFERENT DEVICE TO COMPLETE THE PROCEDURE. THE PROCEDURE TYPE IS UNKNOWN. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866788 ↗
• MalfunctionMay 14, 2021Complete Blockage; Complete Blockage

  THE CUSTOMER REPORTED THAT THE NURSE WAS CHECKING THE DEVICE FOR PATENCY USING AIR BOLUS AND DETERMINED IT WOULD NOT BOLUS AIR. ALL TROUBLESHOOTING WAS PERFORMED. AFTER TESTING WITH AND WITHOUT BEING ATTACHED TO THE PORT, THE ISSUE SEEMED TO BE WITH THE PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829011 ↗
• MalfunctionMay 5, 2021Complete Blockage; Complete Blockage

  THE CUSTOMER REPORTED THAT THE NURSE WAS CHECKING THE DEVICE FOR PATENCY DURING USE USING AIR BOLUS AND DETERMINED THAT IT WOULD NOT BOLUS AIR. ALL TROUBLESHOOTING WAS PERFORMED. AFTER TESTING WITH AND WITHOUT THE PORT ATTACHED, THE ISSUE SEEMED TO BE WITH THE PORT. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2021 STATED THAT THE CUSTOMER WAS TRYING TO PUSH AIR THROUGH THE FEED/MED ONLY PURPLE PORT TO CHECK FOR ANY BLOCKAGES. THE CUSTOMER CONFIRMED THAT THEY DID HAVE THE DIAL TURNED TO THE CORRECT PORT BUT THEY WERE UNABLE TO BOLUS ANY AIR. THE CUSTOMER THEN REMOVED THE ENTIRE MULTIFUNCTIONAL PORT AND PUSHED AIR THROUGH THE TUBING WITH A SYRINGE WHICH WORKED FINE. FOR THIS REASON, THE CUSTOMER FEELS THAT THERE IS SOME SORT OF BLOCKAGE IN THE MULTIFUNCTIONAL PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777208 ↗
• MalfunctionMar 18, 2021Suction Failure; Suction Failure

  THE CUSTOMER REPORTED THAT A 16FR SALEM SUMP WAS PLACED WITH THE INCLUDED MULTI-FUNCTIONAL PORT ATTACHED AND IT WOULD NOT SUCTION. THE MULTI-FUNCTIONAL PORT WAS REPLACED WITH THE SAME ISSUE OCCURRING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11518404 ↗
• MalfunctionJul 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE TIP OF THE DRAIN BROKE OFF WHEN THE DRAIN WAS STRAIGHTENED OUT BY PROVIDER FROM PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10227335 ↗
• MalfunctionMar 3, 2020Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT THE TIP OF THE FEEDING TUBE FORMED A "C" SHAPE AND SEEMED TO KINK ON ITSELF. THEY TRIED TO ADMINISTER FEED, BUT IT WOULD NOT GO THROUGH. THEY REMOVED THE DEVICE AND REPLACED IT WITH A FEEDING TUBE FROM ANOTHER MANUFACTURER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9779927 ↗
• MalfunctionJan 28, 2020Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THE NASOGASTRIC TUBE WAS HAVING ISSUE MAINTAINING ADEQUATE SUCTION. THE NASOGASTRIC TUBE WAS REMOVED FROM THE PATIENT AND WAS FOUND TO BE CRACKED AT THE TRANSITION POINT OF THE TUBE AND WHERE THE ENFIT PORT INSERTS. THE CUSTOMER FURTHER STATED THAT THE PATIENT HAD EXPERIENCED INTERMITTENT DISCOMFORT DUE TO THE INADEQUATE SUCTION, BUT THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9639425 ↗
• MalfunctionDec 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE BLUE MULTI FUNCTIONAL PORT WAS LEAKING THE TUBE FEED AND MEDICATION OUT OF THE BACK DURING PATIENT USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9452050 ↗
• MalfunctionOct 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT AFTER THE NURSE PUSHED 20 CC OF AIR INTO ARV PORT BEFORE AND AFTER FLUSHING, THE NURSE WENT TO SUCTION ON THE MULTIFUNCTION PORT SALEM SUMP AND TURNED THE DIAL IN THE DIRECTION OF SUCTION, AS WELL AS LOCKING IT IN PLACE, BUT STILL EXPERIENCED LEAKING OUT OF THE FEED/MED PORT, EVEN THOUGH THE DIAL WAS POSITIONED FOR SUCTION AND CLOSED FOR FEED/MED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9191605 ↗
• MalfunctionSep 17, 2019Complete Blockage; Complete Blockage

  THE CUSTOMER REPORTED THAT THE ENFIT MULTIFUNCTION PORT WAS NOT SUCTIONING PROPERLY. THE GASTRIC CONTENT WAS GETTING STUCK OR CLOGGED IN THE SUCTION PORT AND PREVENTING THE SUCTION TO OCCUR. THE HOLE IS SMALL AND THE GASTRIC CONTENT IS TOO THICK TO SUCTION THROUGH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9075327 ↗