MALECOT RUSSEL GASTROSTOMY CATHETER
Received Nov 11, 2005 · Event occurred Sep 28, 2005
Report 1820334-2005-00296 · MDR key 755673
Device
Generic name
Catheter
Manufacturer
Cook, Inc.Model number
NACatalog number
ULT10.2-NT-23-P-NS-
Lot number
UNK
Product problems
- Migration or Expulsion of Device
- Replace
- Material Separation
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
CATHETER WAS PLACED IN AN OUTPT IN 2005. IT WAS SPONTANEOUSLY EXITED ON THE SAME DAY. THE PHYSICIAN FELT THIS SITUATION OCCURRED DUE TO THE SOFTER MATERIAL OF THE TUBING. A REPLACEMENT WAS USED.
Additional Manufacturer Narrative
EVALUATION: THE DEVICE WAS RETURNED IN A USED CONDITION. AN EXAMINATION FOUND THE INNER CATHETER SLIGHTLY ELONGATED NEAR THE BLACK INDICATOR LINE. DURING TESTING, THE INNER CATHETER SEPARATED FROM ITS BONDED POSITION AT THE DISTAL TIP EASILY WHEN PULLED. AN EXAMINATION OF THIS AREA FOUND NO EVIDENCE THAT THE TUBING WAS PROPERLY BONDED AT TIME OF MANUFACTURE.