Salem Sump 7771410ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521582729), received between Nov 17, 2022 and Oct 8, 2024 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionOct 8, 2024Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE TIP OF THE COVIDIEN SALEM SUMP POPPED RIGHT OFF. ADDITIONAL INFORMATION RECEIVED ON 14SEP2023 STATED THAT THE INCIDENT OCCURRED PRIOR TO PATIENT INSERTION. THE DOCTOR NOTICED THE TIP WAS BENT AND IT SNAPPED OFF WHEN STRAIGHTENING THE TIP. THE TIP DID NOT ENTER THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397257 ↗
• InjuryDec 15, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT AFTER MMO (MUCOSAL MELANOMAS OF THE ORAL CAVITY) SURGERY, THE SURGEON PLACED A NASOGASTRIC TUBE (NGT) TO SUCTION/EMPTY STOMACH FOR ANY BLOOD OR IRRIGATION THAT MIGHT HAVE WENT DOWN THE STOMACH. AFTER SUCTIONING, THE RESIDENT TOOK OUT THE NGT AND NOTICED THAT TIP OF THE TUBE WAS MISSING. THEY DID X-RAY BUT UNABLE TO LOCATE THE TIP. THEY HAD TO GO TO CT SCAN, AND THEY WERE ABLE TO LOCATE WHERE EXACTLY THE TIP WAS, FROM THERE THEY WENT BACK TO OR AND HN SURGEON RETRIEVED THE MISSING PART OF THE NGT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE PATIENT IS DOING FINE AND RECOVERED NORMALLY FROM THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18337003 ↗
• MalfunctionNov 17, 2022Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THEY WERE HAVING ISSUES WITH THE ENFIT GETTING CLOGGED WHILE USING IT ON A PATIENT FOR SUCTION. THEY COULDN¿T FIND ANY MARKINGS ON THE ACTUAL TUBE ITSELF THAT SAID 14 FR AND WHEN THEY LOOKED IN THEIR OMNICELLS (IN THE HOPE THEY COULD FIND A NORMAL SALEM SUMP), THEY STOCKED SIZE WAS 18 FR. 1A INSERTED THE TUBE EARLIER IN THE DAY BEFORE HE WAS UPGRADED, AND THE CUSTOMER WONDERED IF IT WAS TRULY A 14 FR OR THEY CLICKED THE WRONG SIZE. THEY OPENED ONE OF THE 18 FR PACKAGES AND CHANGED THE ADAPTER TO THE ONE IN THAT PACKAGE ON THE OFF CHANCE THE ADAPTER WAS ALSO A BIGGER SIZE, BUT IT WAS NOT. THE GASTRIC CONTENT WOULD FLOW THROUGH THE 14 FR TUBE PRETTY EASILY IT SEEMED. FOR A WHILE WE LEFT THE TUBE OPEN ONTO A CHUCK PAD JUST TO LET HIM DRAIN WHILE THEY TROUBLESHOOTED. EVEN THE CHUNKY SLUDGE DRAINED FROM THE OPEN TUBE. THEY WOULD MANUALLY HOLD THE SUCTION TUBING TO THE END OF HIS NASOGASTRIC TUBE (NGT) AND IT WOULD PULL CONTENTS. BUT THE MOMENT THEY RE-ATTACHED THE BLUE ADAPTOR THEY WOULD HAVE TROUBLE. FOR EXAMPLE, WHILE THEY TROUBLESHOOTED FOR AN HOUR AFTER BRINGING THE PATIENT TO THE FLOOR, THEY WOULD DISCONNECT THE ADAPTOR AND FLUSH THAT PIECE OUT, RECONNECT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15816640 ↗