MalfunctionPXI
SAFE-T-CENTESIS
Received May 14, 2026 · Event occurred Apr 3, 2026
Report 25169052 · MDR key 25169052
Device
Generic name
Thoracentesis Tray
Manufacturer
Carefusion 2200, IncModel number
PIG1260TCatalog number
PIG1260T
Lot number
REKX3924
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A MANUFACTURER DEFECT IN THORACENTESIS KIT, SAFE T-CENTESIS 6FR CATHETER DRAINAGE TRAY REF PIG1260T, LOT NUMBER REKX3924, UPON OPENING THE KIT, DOCTOR IDENTIFIED THAT THE CATHETER DRAINAGE DEVICE WAS CURVED/ BENT. THE SAID SUPPLY WAS THEN TAKEN OUT OF THE FIELD AND A NEW SAFE T-CENTESIS 6FR CATHETER DRAINAGE TRAY OPENED.