MalfunctionFCG

SAFE-T PLUS

Received Mar 7, 2018 · Event occurred Feb 21, 2018

Report 7320354 · MDR key 7320354

Device

Generic name

Biopsy Needle

Manufacturer

Sterigenics U.s., Llc

Catalog number

TPT1000SP

Lot number

0001167204

Product problems

Break

Patient

60 YR

No Known Impact Or Consequence To Patient
No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

RADIOLOGIST NOTICED BROKEN VIAL OF LIDOCAINE WHEN STERILE PREPACKAGED TRAY WAS OPENED. MANUFACTURER RESPONSE FOR SAFE-T PLUS THORA-PARA 8 FR CATHETER DRAINAGE TRAY, SAFE-T PLUS (PER SITE REPORTER). WAITING ON REPLY.