NONE

Report

• Report Number: 1419727-2014-00001
• Event Type: Malfunction
• Date Received: April 16, 2014
• Product Code: EYI
• Removal / Correction Number: NA
• Report Source: Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

THIS IS A RESPONSE TO THE USER FACILITY'S INITIAL REPORT. THE DEVICE WAS RETURNED AND VISUALLY INSPECTED. OUR INVESTIGATION REVEALED THAT THE MOLDING PROCESS RESULTED IN AN INCOMPLETE DEVICE. ALTHOUGH EACH OF THESE MOLDED DEVICES COMPLETES TWO QUALITY ASSURANCE CHECKS INCLUDING 100% VISUAL INSPECTION, THIS DEVICE WAS NOT DETECTED PRIOR TO SHIPMENT. WE HAVE HAD NO OTHER REPORTS OF THIS NATURE AND BELIEVE IT TO BE AN ISOLATED INCIDENT.

Description of Event or Problem · 1

(B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
234123	NONE	NONE	EYI

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Information

Product problems · 1

• Break

Source type · 1

• User facility

Type of report · 1

• Initial submission