MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE ONE STEP CANNULA SYSTEM.(23 GAUGE / 0.6 MM)

Catalog Number	1272.ED206
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation report stated that the blade is not cleaned at dorc, however it might be possible that this sample has skipped our attention during our quality inspection.If this complaint occurred during surgery it is possible that the contaminated part would lead to foreign body reaction thus end up with adverse effect.In retrospective review, this incident has been concluded as reportable.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre (b)(4)).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6) 2017.All available information has been disclosed.This complaint has now been closed.Additional information on the investigation revealed this may be the vapor of the glue but cannot say for certain.
Event or Problem Description
The complainant informed dutch that the cannula had what looked to be a white residue on the blade.No injury to the patient occured.A picture was taken and will be sent by email.

• Brand Name: DISPOSABLE ONE STEP CANNULA SYSTEM.(23 GAUGE / 0.6 MM)
• Common Device Name: DISPOSABLE ONE STEP CANNULA SYSTEM.(23 GAUGE / 0.6 MM)
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7484895
• Report Number: 1222074-2018-00095
• Device Sequence Number: 16557263
• Product Code: HMX
• UDI-Device Identifier: 08717872002415
• UDI-Public: 08717872002415
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2015

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: 1272.ED206
• Device Lot Number: 2000366892
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1