MalfunctionGBW

PUDENZ PERITONEAL LOW PRESSURE CATHETER

Received Mar 28, 2002

Report 2648988-2002-00004 · MDR key 385607

Device

Generic name

Csf Catheter

Manufacturer

Heyer-schulte Neurocare Inc.

Model number

Catalog number

NL850-1390

Lot number

UNK

Product problems

Break
Replace
Device, removal of (non-implant)

Patient

Surgical procedure, repeated

Narrative

Description of Event or Problem

ONE SAMPLE WILL BE RETURNED WHICH WAS USED BY A PATIENT WITH NO INFECTIOUS DISEASE. THE PHYSICIAN REMOVED THE CATHETER FROM THE PATIENT AND IMPLANTED A NEW CATHETER. THE BROKEN PART WAS FOUND TO EXIST ON THE REMOVED CATHETER. IT IS UNKNOWN IF PATIENT INJURY OCCURRED BUT INTERVENTION WAS REQUIRED, CATHETER WAS REPLACED.