Salem Sump 8888264960 (UDI 10884521007727)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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521007727), received between Jul 28, 2017 and Jul 28, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Hole In Material” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Hole In Material1
- Leak/Splash1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2017Hole In Material; Leak/Splash; Hole In Material; Leak/Splash
ACCORDING TO THE INITIAL REPORTER THEY DISCOVERED A HOLE IN THE TUBE AT THE TOP OF THE BLUE VENT PORT THROUGH THE SUMP TUBE OPENING WHICH CAUSED THE SUMP TO LEAK AT THE BLUE VENT JUNCTION. THE ISSUE WAS DISCOVERED AFTER PLACEMENT AND DURING USE ON A PATIENT. THEY'RE MOVED IT AND PUT ANOTHER ONE IN WHICH WAS ALSO LEAKING. THEY FOUND FOUR OTHERS FROM THE SAME LOT NUMBER THAT ALL APPEARED TO HAVE A HOLE ON THE BLUE VALVE AT THE JUNCTION POINT TO THE CLEAR SUMP TUBING. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6750063 ↗
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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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