inforMED
GBW

PUDENZ PERITONEAL CATHETER LOW

Received Jan 19, 1999 · Event occurred Oct 12, 1998

Report 2132740-1999-00003 · MDR key 206467

Device

Generic name

Peritoneal Catheter

Model number

NL850-1390

Catalog number

NL850-1390

Lot number

UNK

Product problems

  • Explanted
  • Replace

Patient

3 YR

  • Surgical procedure, repeated
  • Swelling

Narrative

Description of Event or Problem

IT WAS REPORTED THAT A VALVE WAS REMOVED FROM A PT (CHILD) DUE TO AN ALLEGED CONNECTOR COMING OFF OR BREAKING AT THE PROXIMAL SIDE ON 10/12/98. ON 10/10/98 SWELLING WAS OBSERVED AROUND THE VALVE. THE PHYSICIAN REPLACED THE VALVE WITH ONE OF ANOTHER MFR. THERE WAS NO PT INJURY.