MAUDE Adverse Event Report: D.O.R.C INTERNATIONAL VFI PACK FOR SILICONE OIL SYRINGES

Catalog Number	1363.DD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/12/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The article was not returned therefore the root cause of this problem could not be traced.Since the incident happened during surgery, it can harm the operator due to broken (into pieces) or patient.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer.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 provided.
Event or Problem Description
A report has been received from (b)(6).Spray has been broken during injection.Can you check if no excessive pressure is applied to the syringe during injection? we have a problem this time.There is no information of patient injury, no more available information, and the sample has been discarded.

• Brand Name: VFI PACK FOR SILICONE OIL SYRINGES
• Common Device Name: VFI PACK FOR SILICONE OIL SYRINGES
• Manufacturer (Section D): D.O.R.C INTERNATIONAL; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 6950400
• Report Number: 1222074-2017-00019
• Device Sequence Number: 13758427
• Product Code: HQC
• UDI-Device Identifier: 08717872007250
• UDI-Public: 08717872007250
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2014

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: 1363.DD
• 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: 05/12/2014
• Initial Report FDA Received Date: 10/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1