inforMED
MalfunctionFEG

SALEM SUMP

Received May 14, 2026 · Event occurred May 11, 2026

Report 1423537-2026-00156 · MDR key 25173032

Device

Generic name

Tube, Double Lumen For Intestinal Decompression And/or Intubation

Model number

8888266122

Catalog number

8888266122

Lot number

2525416364

Product problems

  • Break

Patient

NA · Unknown

  • Anxiety

Narrative

Description of Event or Problem

THE CUSTOMER REPORTED THAT DURING AN ATTEMPT TO REMOVE THE PLUG FROM THE NG TUBE IN ORDER TO RECONNECT IT TO SUCTION, THE PLUG BROKE AND BECAME STUCK INSIDE THE TUBE. AS A RESULT, THE NG TUBE COULD NOT BE RECONNECTED TO SUCTION. ATTEMPTS WERE MADE TO REMOVE THE BROKEN PLUG; HOWEVER, THE PIECES CAME OUT IN FRAGMENTS AND PART OF THE PLUG REMAINED LODGED INSIDE THE TUBE. THE TUBE WAS THEREFORE UNABLE TO BE USED FOR SUCTION. FURTHER ASSISTANCE WAS REQUIRED TO ADDRESS THE ISSUE. THE CUSTOMER STATED THAT THE PLUG THAT COMES WITH THE TUBING APPEARED TO BE THE ISSUE. THEY ALSO HAVE SEPARATE PLUGS AVAILABLE, AND WHEN THEY USED ONE OF THOSE, IT DETACHED EASILY WITHOUT ANY PROBLEMS. ADDITIONAL INFORMATION RECEIVED ON 13MAY2026 CONFIRMED THAT THE ISSUE WAS WITH THE ARV VALVE. THEY CANNOT CONFIRM THE REPORTED LOT NUMBER AS THE STAFF PROVIDED THE NUMBERS THAT THEY HAD AT THE TIME. THEY DIDN¿T HAVE TO INSERT ANOTHER TUBE, BUT THE PATIENT WAS QUITE ANXIOUS WHEN THEY INITIALLY COULDN¿T REMOVE IT. STAFF ASSISTED BY APPLYING COUNTER PRESSURE WHILE TWO PEOPLE ATTEMPTED TO REMOVE IT, BUT IT WOULDN¿T BUDGE. THEY THEN CALLED ANOTHER PERSON IN TO STABILIZE THE TUBE AT THE PATIENT¿S NOSE TO ENSURE THEY DIDN¿T ACCIDENTALLY DISLODGE IT.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.