inforMED
MalfunctionEZK

ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET

Received Jun 26, 2009 · Event occurred Jan 26, 2009

Report 1820334-2009-00356 · MDR key 1413342

Device

Generic name

Ezk Catheter, Retention Type

Manufacturer

Cook, Inc.

Model number

NA

Catalog number

WOGS-1200

Lot number

UNK

Product problems

  • Material Separation
  • Other (for use when an appropriate device code cannot be identified)

Patient

75 YR

  • Other (for use when an appropriate patient code cannot be identified)

Narrative

Description of Event or Problem

COOK GASTROSTOMY FEEDING TUBE WAS PLACED IN 2009, PULLED AWAY FROM THE PLASTIC HUB AND THE THREAD BROKE IN THE SAME MONTH. IT COULD NOT BE REATTACHED, AND THE TUBE HAD TO BE REPLACED. WE WERE LATER ADVISED THAT THIS WAS AN ACCIDENTAL EVENT AS THEY CUT THE THREAD BECAUSE THEY DID NOT KNOW WHAT IT WAS. THE PT WAS TAKEN TO REHAB AND THEN RELEASED.

Additional Manufacturer Narrative

EXPIRATION DATE UNK AS LOT IS UNK. EVALUATION: STILL UNDER INVESTIGATION AT THIS TIME.