inforMED
MalfunctionHMW

LACRICATH LACRIMAL DUCT CATHETER, 3.0MM

Received Feb 7, 2006 · Event occurred Dec 5, 2005

Report 1649914-2006-00006 · MDR key 680862

Device

Generic name

Manual Ophthalmic Surgical Instrument: Lacrymal Dilator

Model number

LDC315

Catalog number

*

Lot number

UNK

Product problems

  • Leak/Splash
  • Replace

Patient

UNKNOWN

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

DURING A PROCEDURE, IT WAS DISCOVERED THAT BOTHE CATHETERS LEADED AT THE HUB. ANOTHER SET OF CATHETERS WERE USED TO COMPLETE THE PROCEDURE WITHOUT ANY COMPLICATIONS. THE COMPLAINT SAMPLES WERE SAVED AND WILL BE RETURNED TO QUEST FOR EVALUATION. THE DEVICE IS PACKAGED IN A KIT. THE PART NUMBER OF THE KIT IS DCP315-BI, LOT 24907. THE PART NUMBER OF THE DEVICE THAT ALLEGEDLY FAILED IS LDS315, LOT UNKNOWN AT THIS TIME (FOUR POTENTIAL LOTS WENT INTO THE KIT). THE MDR WILL BE FILED ON THE LDC315 CODE.