MAUDE Adverse Event Report: D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV DISPOSABLE UNIVERSAL SILICONE INFUSION LINE FOR 23 GAUGE / 0.6 MM CANNULA SYSTEM

Catalog Number	1279.IA
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research (b)(4)).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6) 2017.Assuming worst case during surgery, no irrigation or less irrigation may lead to hypotony therefore is deemed as reportable.No sample was returned, therefore unable to confirm this complaint.All available information has been provided.This complaint has now been closed.
Event or Problem Description
A report has been received from an event that occurred in (b)(6).The following has been reported: " no or minimal irrigation from the infusion line during surgery.During priming there was normal irritation.".

• Brand Name: DISPOSABLE UNIVERSAL SILICONE INFUSION LINE FOR 23 GAUGE / 0.6 MM CANNULA SYSTEM
• Common Device Name: DISPOSABLE UNIVERSAL SILICONE INFUSION LINE FOR 23 GAUGE / 0.6 MM CANNULA SYSTEM
• Manufacturer (Section D): D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands ; NL
• MDR Report Key: 7359485
• Report Number: 1222074-2018-00048
• Device Sequence Number: 1740742
• Product Code: KYG
• UDI-Device Identifier: 08717872003351
• UDI-Public: 08717872003351
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 1279.IA
• Device Lot Number: 2000355594
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1