inforMED
MalfunctionGCD

7 FR BLAKE JP ROUND DRAIN

Received Apr 16, 2025 · Event occurred Apr 1, 2025

Report MW5169139 · MDR key 21850648

Device

Generic name

Connector, Catheter

Model number

SU130-320

Product problems

  • Entrapment of Device

Patient

9 YR · Unknown

  • Foreign Body In Patient
  • Foreign Body In Patient

Narrative

Description of Event or Problem

A 7MM RETAINED PIECE OF JP DRAIN FROM (B)(6) 2024 SURGERY, DRAINS WERE REMOVED WITHOUT ANY CONCERN IN ENT CLINIC (B)(6) 2025. THE UNINTENDED PIECE OF DRAIN WAS NOTED AND REMOVED AFTER DISCOVERED INTRAOPERATIVELY DURING (B)(6) 2025 SURGERY. WAS REMOVED ENDOSCOPICALLY, REMOVAL CONFIRMED BY X-RAY, TUBING SENT TO PATHOLOGY. PLAN TO GO FORWARD IS CT SCAN TO ENSURE NO FURTHER SMALL FRAGMENTS AND IF THERE ARE, WILL BE ABLE TO REMOVE WITH NEXT SURGERY.