inforMED
MalfunctionHMW

LACRICATH LACRIMAL DUCT CATHETER, 3.0MM

Received Sep 19, 2006 · Event occurred Aug 29, 2006

Report 1649914-2006-00097 · MDR key 879969

Device

Generic name

Manual Ophthalmic Surgical Instrument: Lacrymal Dilator

Model number

LDC315

Catalog number

*

Lot number

26228.J02

Product problems

  • Leak/Splash
  • Replace

Patient

YR

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE CATHETER LEAKED FROM A HOLE IN THE TUBING WHERE IT ATTACHES TO THE INFLATION DEVICE (SHE SAID IT WAS SPRAYING OUT). THEY USED ANOTHER KIT TO FINISH THE CASE. THE SAMPLE WAS SAVED AND WILL BE RETURNED TO QUEST. PRODUCT CODE LDC315; LOT NUMBER 26228.J02.