FDA Adverse Event Malfunction Summary report: N

BD PRECISIONGLIDE

MDR report key: 3072403 · Received April 10, 2013

Report

Report Number
3072403
Event Type
Malfunction
Date Received
April 10, 2013
Date of Event
April 2, 2013
Report Date
April 10, 2013
Manufacturer
BECTON DICKINSON
Product Code
FMF
Product Problem
Yes
Report Source
User Facility report
Reporter Location
PA, US

Narratives

Description of Event or Problem · 1

PATIENT UNDERGOING EYE SURGERY FOR TREATMENT OF GLAUCOMA. SURGEON NOTICED SHINY SPECK IN IRIS OF RIGHT EYE. FURTHER EVALUATION NOTED TIP FROM AN INJECTION NEEDLE HAD BROKEN OFF.THE SURGEON DECIDED TO LEAVE THE PARTICLE IN THE EYE. AN ATTEMPT WAS MADE TO REMOVE THE PARTICLE, BUT THIS WAS EMBEDDED IN STROMA AND THE MORE REMOVAL ATTEMPT WAS MADE AS THE BIGGER THE WOUND BECAME. HE DECIDED AT THIS POINT TO LEAVE THE PARTICLE IN THE CORNEA. THIS PARTICLE WAS APPROXIMATELY 0.1 MM IN SIZE. IT WAS BURIED IN THE STROMA. THE SURGEON DID NOT BELIEVE IT WILL CAUSE ANY LONG-TERM DIFFICULTIES. THERE WAS ADDITIONAL FOLLOW UP ON THE PATIENT BY THE SURGEON THE NEXT DAY FOR EVALUATION. NO ONE HAS AN IDEA OF WHAT MAY HAVE CONTRIBUTED TO THIS EVENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?GONIOTOMY, NASAL APPROACH IN THE RIGHT EYE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
151911 BD PRECISIONGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMF BECTON DICKINSON * 1214753

Patients

Seq Age Sex Outcome Treatment
1 2 YR