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

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2015

Event Type  malfunction  

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 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
• Type of Device: 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
• Manufacturer (Section G): D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands ; NL
• Manufacturer Contact: laura smith ; 10 continental dr; exeter, NH 03833 ; 6037538824
• MDR Report Key: 7359485
• MDR Text Key: 103551350
• Report Number: 1222074-2018-00048
• Device Sequence Number: 1
• Product Code: KYG
• UDI-Device Identifier: 08717872003351
• UDI-Public: 08717872003351
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 1279.IA
• Device Lot Number: 2000355594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1