MalfunctionGBW
TAUT INTRODUCER, 3MM X 2.4 MM X 8.9CM
Received Apr 20, 2017 · Event occurred Apr 19, 2017
Report MW5069250 · MDR key 6515345
Device
Generic name
Peritoneal Catheter
Manufacturer
Teleflex MedicalModel number
PI-93Catalog number
PI-93
Lot number
73F160026
Product problems
- Loose or Intermittent Connection
Patient
83 YR
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
RUBBER DIAPHRAGM FROM TELEFLEX MEDICAL TAUT INTRODUCER PERITONEAL CATHETER CAME LOOSE FROM CATHETER AND HAD ENTERED INTO THE PATIENT'S ABDOMINAL CAVITY. DIAPHRAGM WAS IMMEDIATELY RETRIEVED AND REMOVED IN ITS ENTIRETY FROM THE ABDOMINAL CAVITY. DIAGNOSIS OR REASON FOR USE: LAPAROSCOPIC CHOLECYSTECTOMY. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.