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

Catalog Number	1363.DD
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation showed that the dorc vfi pack for silicone oil syringe (1363.Dd) can lead to breaking of the glass syringe containing the dorc silicone oil when mounting the syringe in the adapter.Recall on 1363 dd has been initiated and update to design.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.
Event or Problem Description
Dorc became aware of a potential performance issue concerning the vfi adapter of the vfi pack for silicone oil syringes during use in combination with glass prefilled silicone oil syringe.Investigation showed that the dorc vfi pack for silicone oil syringe (1363.Dd) can lead to breaking of the glass syringe when mounting the syringe in the adapter.No injury reported.

• 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: 7515521
• Report Number: 1222074-2018-00130
• Device Sequence Number: 13892803
• Product Code: HQC
• UDI-Device Identifier: 08717872019659
• UDI-Public: 08717872019659
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 10/01/2015

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: 1363.DD
• 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: 10/01/2015
• Initial Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1