MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV UNIVERSAL PVC INFUSION LINE FOR 23G CANNULA SYSTEM FOR VFI/VFE

Catalog Number	1279.IA25
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The investigation showed there is a piece of silicone in the infusion line that is restricting the flow.Upon the retrospective review, this complaint occurred during surgery.The piece of silicone was observed during mid of surgery.Hence this incident has been concluded as reportable.The associated risk is hypotony, however there is no information of patient harm.The complaint is confirmed.All available information has been disclosed.The complaint has now been closed.
Event or Problem Description
The complainant informed dutch that the infusion line had some sort of plug in it that was restricting flow.The issue was noticed approx.Halfway through a case / surgery.No injury to the patient occurred as a result of this incident.The complaint item will be sent to dorc.All information pertaining to this incident has been disclosed.

• Brand Name: UNIVERSAL PVC INFUSION LINE FOR 23G CANNULA SYSTEM FOR VFI/VFE
• Common Device Name: UNIVERSAL PVC INFUSION LINE FOR 23G CANNULA SYSTEM FOR VFI/VFE
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7506262
• Report Number: 1222074-2018-00116
• Device Sequence Number: 10815470
• Product Code: HQC
• UDI-Device Identifier: 08717872003351
• UDI-Public: 08717872003351
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2015

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: 1279.IA25
• Device Lot Number: 2000363231
• 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: 07/21/2015
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1