inforMED
MalfunctionPXI

THORA/PARA KIT

Received May 11, 2026 · Event occurred May 5, 2026

Report 25136160 · MDR key 25136160

Device

Generic name

Thoracentesis Tray

Lot number

REKY3408

Patient

NA · Unknown

  • Pain

Narrative

Description of Event or Problem

PRESENTED TO PATIENT'S ROOM FOR BEDSIDE PARACENTESIS. OPENED A BRAND NEW, UNDAMAGED THORA/PARA KIT (MANUFACTURER CAREFUSION, LOT NUMBER REKY3408) AND ADMINISTERED 5 ML FROM ONE KIT-PROVIDED 1% LIDOCAINE (LOT NUMBER AE5040) TO THE PATIENT. AFTER ADMINISTERING LIDOCAINE, PATIENT STATED THAT HE COULD STILL FEEL SHARP PAIN. ADMINISTERED ADDITIONAL 5 ML OF LIDOCAINE FROM SECOND VIAL (SAME LOT NUMBER). PATIENT STATED THAT HE COULD STILL FEEL SHARP PAIN. OBTAINED 1% LIDOCAINE FROM SEPARATE KIT WITH DIFFERENT LOT NUMBER AND ADMINISTERED TO PATIENT WITH NOW ADEQUATE ANESTHESIA. THERE WERE NO OTHER COMPLICATIONS FROM THE PROCEDURE.