Salem Sump 8888264945 (UDI 10884521007697)Recalls & reported problems
Cardinal Health, Inc. · Dual Lumen Stomach Tube · Class 2
All models of Salem Sump (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521007697), received between Sep 26, 2019 and Aug 13, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Crack” (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
Device problems
- Crack3
- Suction Problem3
- Break1
Patient problems
- No Consequences Or Impact To Patient3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2020Break; Break
THE CUSTOMER REPORTED THE RN OPENED A NEW NG TUBE PACKAGE PRIOR TO INSERTION AND NOTICED THAT THE TIP WAS PARTIALLY BROKEN OFF.
Patient problems: No Patient Involvement
MAUDE report 10403824 ↗MalfunctionSep 26, 2019Crack; Suction Problem; Crack; Suction Problem
THE CUSTOMER REPORTED THAT THERE WAS A SUSPECTED FINE CRACK IN THE TUBING, RESULTING IN INEFFECTIVE ASPIRATION OF THE TUBE WITH A SIMULTANEOUS FAINT SOUND OF AIR. THE PATIENT HAD THE TUBE INSERTED THE DAY PRIOR. THE CUSTOMER FURTHER STATED THE PRODUCT FAILED TO ASPIRATE THE GASTRIC FLUIDS BECAUSE IT WAS SPLIT AND SPILLING OUT OF THE SIDES. THE TUBING HAD TO BE CHANGED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9126400 ↗MalfunctionSep 26, 2019Crack; Suction Problem; Crack; Suction Problem
THE CUSTOMER REPORTED THAT THERE WAS A SUSPECTED FINE CRACK IN THE TUBING, RESULTING IN INEFFECTIVE ASPIRATION OF THE TUBE WITH A SIMULTANEOUS FAINT SOUND OF AIR. THE PATIENT HAD THE TUBE INSERTED THE DAY PRIOR. THE CUSTOMER FURTHER STATED THE PRODUCT FAILED TO ASPIRATE THE GASTRIC FLUIDS BECAUSE IT WAS SPLIT AND SPILLING OUT OF THE SIDES. THE TUBING HAD TO BE CHANGED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9126390 ↗MalfunctionSep 26, 2019Crack; Suction Problem; Crack; Suction Problem
THE CUSTOMER REPORTED THAT THERE WAS A SUSPECTED FINE CRACK IN THE TUBING, RESULTING IN INEFFECTIVE ASPIRATION OF THE TUBE WITH A SIMULTANEOUS FAINT SOUND OF AIR. THE PATIENT HAD THE TUBE INSERTED THE DAY PRIOR. THE CUSTOMER FURTHER STATED THE PRODUCT FAILED TO ASPIRATE THE GASTRIC FLUIDS BECAUSE IT WAS SPLIT AND SPILLING OUT OF THE SIDES. THE TUBING HAD TO BE CHANGED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9126331 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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