MAUDE Adverse Event Report: D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV EVA TDC VITRECTOMY PACK VGPC INPUT 23G

Catalog Number	8310.23G02
Medical Device Problem Code	Physical Property Issue (3008)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/25/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No sample was returned, therefore unable to confirm this complaint.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)(4)) during a tele-conference on 05/31/2017.All available information has been provided.This incident occurred during surgery.Small plastic parts (foreign particles) came trough the infusion line.Since this can cause injury to the patients eye, this complaint is concluded as reportable.Investigation could not reveal the root cause, due to not receiving the faulty article.Therefore this complaint is closed.
Event or Problem Description
Small plastic parts came trough the infusion line.No further information is available.No sample is available.

• Brand Name: EVA TDC VITRECTOMY PACK VGPC INPUT 23G
• Common Device Name: EVA TDC VITRECTOMY PACK
• Manufacturer (Section D): D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 7245855
• Report Number: 1222074-2018-00020
• Device Sequence Number: 1316722
• Product Code: HQE
• UDI-Device Identifier: 08717872021010
• UDI-Public: 08717872021010
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 08/25/2014

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: 8310.23G02
• Device Lot Number: 2000363743
• 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: 08/25/2014
• Initial Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1