inforMED
MalfunctionPXI

SAFE-T-CENTESIS DRAINAGE SYSTEM

Received Jun 8, 2026 · Event occurred Jun 1, 2026

Report 25427559 · MDR key 25427559

Device

Generic name

Thoracentesis Tray

Lot number

REKZ2033

Patient

NA · Unknown

  • Ascites

Narrative

Description of Event or Problem

TICU PA [TRAUMA INTENSIVE CARE UNIT PHYSICIAN ASSISTANT] REPORTS ISSUE WITH SAFE-T-CENTESIS DRAINAGE TRAY. PA REPORTS WHEN NEEDLE INSERTED, NO ASCITES FLUID COMES OUT THROUGH CATHETER SYSTEM, BUT WHEN CATHETER SYSTEM REMOVED FROM NEEDLE, ASCITES COMES OUT.