MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DORC VFI CONNECTOR BETWEEN DORC SYSTEM & 1363.DD

Catalog Number	1363.DD
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed during the retrospective review.The investigation showed that the article that was returned, is from a batch of the recall last year.The product was returned in a pouch that had a new lot number.We checked the batch records, there where no deviations found.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer ((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.
Event or Problem Description
During the past week we experienced a new 1363.Dd exploded.This lot number is not one of those you happened to recall in 2015.Sample is available.

• Brand Name: DORC VFI CONNECTOR BETWEEN DORC SYSTEM & 1363.DD
• Common Device Name: DORC VFI CONNECTOR BETWEEN DORC SYSTEM & 1363.DD
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7562579
• Report Number: 1222074-2018-00161
• Device Sequence Number: 2221927
• Product Code: HQC
• UDI-Device Identifier: 08717872007250
• UDI-Public: 08717872007250
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 03/18/2016

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: 1363.DD
• Device Lot Number: 2000374750
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2016
• Initial Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1