WILLS-OGLESBY GASTROSTOMY CATHETER
Received Dec 13, 2007 · Event occurred Nov 13, 2007
Report 1820334-2007-00489 · MDR key 963381
Device
Generic name
Ezk- Special Set
Manufacturer
Cook, Inc.Model number
NACatalog number
ULT12.0-38-35-P-12
Lot number
F2094835
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
YR
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
INFO WAS PROVIDED THAT THE PHYSICIAN EXPERIENCED GREAT DIFFICULTY IN REMOVING THE TUBE FROM THE PT, REQUIRING INCREASED AMOUNTS OF ANALGESIA TO THE PT. UPON REMOVAL, IT WAS NOTED THAT THE TUBE HAD TIED ITSELF INTO A KNOT.
Additional Manufacturer Narrative
EVALUATION: NO PRODUCT WAS RETURNED TO ASSIST IN OUR INVESTIGATION, HOWEVER, PHOTOS WERE PROVIDED, WHICH SHOWED THE TUBING HAS KNOTTED. BASED ON THE INFO PROVIDED AND THE CONDITION OF THE DEVICE IN THE PHOTO IMAGES, IT IS FEASIBLE TO SAY THE KNOT FORMED DURING PLACEMENT, AS THE RESULT OF PT ANATOMY OR POSSIBLE PT INTERVENTION. IT SHOULD BE NOTED THIS IS A SOFT, PLIABLE TUBING DESIGNED FOR PT COMFORT, THAT CAN BE MANIPULATED.