Salem Sump 7771810E (UDI 10192253010435)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10192253010435), received between Nov 12, 2024 and Feb 9, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2026Material Separation

  THE CUSTOMER REPORTED APPROXIMATELY 1.6CM OF THE TIP OF THE TUBE BROKE OFF INTO A PATIENT'S SINUSES ON REMOVAL, WHICH LED TO ADDITIONAL IMAGING, ADDITIONAL PROCEDURES, PROLONGED VENTILATOR SUPPORT, AND HIGHER LEVEL OF CARE. PER ADDITIONAL INFORMATION PROVIDED BY THE REPORTER ON 06FEB2026, THE FOLLOWING IMAGING WAS PERFORMED: (B)(6) 2026 1848: PORTABLE CXR, (B)(6) 2026 2143: CT HEAD WITHOUT CONTRAST, (B)(6) 2026 2145: CT NECK WITHOUT CONTRAST, (B)(6) 2026 0927: XR SKULL 1-3 VIEWS PORTABLE, (B)(6) 2026 1434: CT HEAD WITHOUT CONTRAST, (B)(6) 2026 1435: CT NECK WITHOUT CONTRAST, AND (B)(6) 2026 1435: CT CHEST WITHOUT CONTRAST. THE FOLLOWING PROCEDURES WERE PERFORMED: EGD PERFORMED DURING ORIGINAL SURGERY BY SURGICAL TEAM AND ENT PERFORMED NASOPHARYNGEAL AND OROPHARYNGEAL SCOPES DURING ORIGINAL SURGERY. REGARDING THE PROLONGED VENTILATOR SUPPORT, THE PATIENT REMAINED INTUBATED UNTIL (B)(6) 2026 AT 1231 DUE TO POSSIBLE CHOKING HAZARD (41H 6M OF PROLONGED VENT TIME) (B)(6) 2026 1925-(B)(6) 2026 1231). THE PATIENT REQUIRED ICU STAY DUE TO THE VENTILATOR REQUIREMENT. THE NG TIP WAS FOUND ON (B)(6) AT 0800 TO BE IN THE PATIENT¿S STOMACH ON REPEAT IMAGING. THE PATIENT WAS DISCHARGED TO PRISON

  Patient problems: Foreign Body In Patient

  MAUDE report 24296298 ↗
• MalfunctionNov 12, 2024

  NASOGASTRIC (NG) TUBE WAS PLACED IN PATIENT IN THE EMERGENCY DEPARTMENT (ED), AND PATIENT WAS TRANSFERRED TO THE 6TH FLOOR. THE REGISTERED NURSE (RN) RECEIVED ORDERS TO PLACE CONTRAST DOWN THE NG TUBE. WHEN THE RN TRIED TO PUT THE CONTRAST DOWN THE NG TUBE, IT WAS LEAKING FROM THE HARD PLASTIC PIECE AND FROM THE AREA AROUND THE AIR VENT WHERE IT ATTACHES TO THE MAIN TUBE. NG TUBE WAS REMOVED AND REPLACED WITH ANOTHER NG TUBE. NO KNOWN HARM TO THE PATIENT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662657 ↗