MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V. EVA NEXUS¿ POSTERIOR 25G TDC PACK; SURGICAL PACKS AND KITS

Catalog Number 9310.25G01

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2023

Event Type  malfunction  

Event Description

We have been informed that during surgery when silicone oil was being injected, the infusion hose disconnected.Most of the silicone oil had been injected into the eye when this happened (80%+).No report that actual patient harm occurred or surgery was prolonged > 30 min.

Manufacturer Narrative

In case of a product return, the device will be investigated, otherwise we will review the device history record, and/or any log files if available, or try to replicate the problem on similar product.As investigations on the actual product or representative sample of a batch may alter the device, we request to inform us within 7 days after submission of this report, in case the investigations that alter the device should be halted until approval of the nca, as per article 89 of eu-mdr.

Event Description

We have been informed that during surgery when silicone oil was being injected, the infusion hose disconnected.Most of the silicone oil had been injected into the eye when this happened (80%+).No report that actual patient harm occurred or surgery was prolonged > 30 min.

Manufacturer Narrative

In regard to this event, the product has been received and investigated.Visual inspection revealed that the infusion line used for silicone oil injecting during surgery is a regular infusion line which is intended for infusion of aqueous solutions (bss) and not for viscous fluids (silicone oil).No corrective or preventive actions can be implemented until the investigation has been completed.The investigation is pending final review and is awaiting trending analysis.

Event Description

We have been informed that during surgery when silicone oil was being injected, the infusion hose disconnected.Most of the silicone oil had been injected into the eye when this happened (80%+).No report that actual patient harm occurred or surgery was prolonged > 30 min.

Manufacturer Narrative

In regard to this complaint, a disposable eva air fluid dual tube set was received.As received, a second 3-way stop cock was connected to the tube set.A silicone oil syringe and an infusion line connector were attached to this 3-way stop cock.In addition to the tube assembly, the infusion line that was disconnected from the infusion line connector was received.Visual inspection showed that the involved infusion line was in fact the 25 gauge high flow infusion line from the eva aveta cannula set that was included in the eva nexus pack.This particular product is for the infusion of aqueous solutions (bss) and not for viscous fluids (silicone oil).For viscous fluid injection, usage of a universal pvc infusion line for vfi/vfe is recommended.This universal pvc infusion line may be used for both aqueous solutions and viscous fluids.Based upon this complaint and situation analysis 2023-0012, to perform an update to include the risks related to the foreseeable mis-use of the infusion line for vfi in the risk analysis (ecf 2023-400) a project has been initiated to update the instructions for use to prevent the use of the regular infusion line for silicone oil.

• Brand Name: EVA NEXUS¿ POSTERIOR 25G TDC PACK
• Type of Device: SURGICAL PACKS AND KITS
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer Contact: petra holland ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 17150590
• MDR Text Key: 318106126
• Report Number: 1222074-2023-00048
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): N
• Reporter Country Code: GR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9310.25G01
• Device Lot Number: 2000438048
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1