inforMED
MalfunctionKDQ

CHEST TUBE SYSTEM

Received Aug 28, 2025 · Event occurred Aug 22, 2025

Report MW5175376 · MDR key 22916452

Device

Generic name

Bottle, Collection, Vacuum

Model number

A-6000-08LF

Lot number

74D2500649

Product problems

  • Defective Device
  • Gas/Air Leak

Patient

54 YR · Male

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

DOCTOR BROUGHT TO MY ATTENTION THAT OVER THE PAST SEVERAL MONTHS, PATIENTS WITH PERSISTENT AIR LEAKS IN THE TELEFLEX CHEST TUBE DRAINAGE SYSTEM HAVE SPONTANEOUSLY RESOLVED AFTER CHANGING THE DRAINAGE SYSTEM. DR. BELIEVES THIS COULD BE DUE TO MANUFACTURING DEFECT AS IT HAS BEEN OCCURRING THROUGHOUT THE HOSPITAL ON DIFFERENT FLOORS.