inforMED
InjuryGBW

MEDI-TECH APD CATHETER SET

Received Jan 5, 1996 · Event occurred Aug 31, 1995

Report 30517 · MDR key 30517

Device

Generic name

Catheter

Manufacturer

Medi-tech, Inc.

Catalog number

20-505

Lot number

H31280

Product problems

  • Break
  • Component(s), broken

Patient

48 YR

  • Abscess

Narrative

Description of Event or Problem

ON 8/9/95 PT HAD A TOTAL PROCTOCOLECTOMY WITH ILEAL J-POUCH ANAL ANASTOMOSIS FOR CHRONIC ULCERATIVE COLITIS. ON 8/31/95 A PRESACRAL ABSCESS WAS NOTED AND DRAINED USING AN ALL PURPOSE DRAINAGE CATHETER SET. UNDER CT GUIDE A 2-3 CM FRAGMENT OF THE DISTAL PORTION OF THE CATHETER BROKE OFF FROM THE TIP AND WAS RETAINED IN THE RIGHT GLUTEAL REGION. UNDER CT GUIDANCE ANOTHER PROCEDURE WAS DONE AND FRAGMENT RETRIEVED.