MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV VFI PACK FOR SILICONE OIL SYRINGES

Catalog Number	1363.DD
Medical Device Problem Code	Physical Property Issue (3008)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product investigation could not be done due to the fact that the customer could not return it to (b)(6).The lot number was checked, this lot had expired on 01-12-2015.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.Syringe ends were very sharp and injured user, as all user harms are serious concluded as reportable.All available information has been disclosed.The complaint is not confirmed.This complaint has now been closed.
Event or Problem Description
Dr.(b)(6) and sister (b)(6) tried to connect syringes to oil infusion pipe and without force (b)(6) injured herself, because the syringe ends were very sharp.

• Brand Name: VFI PACK FOR SILICONE OIL SYRINGES
• Common Device Name: VFI PACK FOR SILICONE OIL SYRINGES
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7538676
• Report Number: 1222074-2018-00150
• Device Sequence Number: 13918619
• Product Code: HQF
• UDI-Device Identifier: 08717872007199
• UDI-Public: 08717872007199
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/15/2015
• Device Catalogue Number: 1363.DD
• Device Lot Number: 2000346172
• 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: 11/04/2015
• Initial Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other