MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV HIGH FLOW INFUSION LINE FOR 20, 23, 25 & 27G CANNULA SYSTEM

Catalog Number 1279.HF

Device Problem Collapse (1099)

Patient Problem Eye Injury (1845)

Event Date 03/10/2017

Event Type  Injury  

Manufacturer Narrative

This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre b.V.).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6) 2018.Incident caused harm to the patient, hence it is reportable all available information has been disclosed.This complaint has now been closed.

Event Description

During surgery the eye collapsed.Perhaps there is something wrong with the gravity input set in cartridges.

• Brand Name: HIGH FLOW INFUSION LINE FOR 20, 23, 25 & 27G CANNULA SYSTEM
• Type of Device: HIGH FLOW INFUSION LINE FOR 20, 23, 25 & 27G CANNULA SYSTEM
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• Manufacturer (Section G): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• Manufacturer Contact: laura smith ; 10 continental dr; bldg 1; exeter, NH 03833 ; 6037786929
• MDR Report Key: 7669803
• MDR Text Key: 113425587
• Report Number: 1222074-2018-00232
• Device Sequence Number: 1
• Product Code: NGY
• UDI-Device Identifier: 08717872018546
• UDI-Public: 08717872018546
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1279.HF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other