MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT); TUBING, NONINVASIVE

Catalog Number 8065750957

Device Problems Disconnection (1171); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.A product sample has been received by the manufacturer and it is awaiting evaluation.(b)(4).

Event Description

A materials coordinator reported when surgeon "hit the foot pedal to inject the silicone", the cannula disconnect and the silicone spilled during a vitrectomy procedure.The product was replaced and the procedure was completed with no harm to the patient.No additional information is expected.

Manufacturer Narrative

Additional information provided.The lot complaint history was reviewed.This is the first complaint for the finished goods lot and for this issue for this lot.The device history record shows the product was released per specifications.The returned sample was visually inspected and silicone oil was present along the luer lock of the infusion cannula.The silicone oil was wiped off the infusion cannula as oil possibly moved around during the transportation processes.In addition, silicone oil around the luer lock can prevent a secure fit on the syringe.A console representing current software version was used to test the sample.The consoles could recognize the viscous fluid control (vfc) by illuminating green on the laser emitting diode (led) ring.The vfc sample was filled with silicone oil per directions for use (dfu); in injection mode the plunger moved freely and met specifications.Extraction mode was then selected and the vfc could aspirate silicone oil into the barrel of the syringe; no anomalies were observed.Pressure was stable during testing.Additionally, all connections were found to fit securely with no abnormalities or detachment.The customer should be reminded that the dfu states to "ensure that the barrel flanges are properly engaged with the adapter," there is also an illustration provided.The root cause of the customer's complaint could not be established; the returned sample functioned per specifications.The investigation did find silicone oil around the luer lock of the infusion cannula, however, it's possible oil may have seeped onto this component during the transportation processes.After an investigation of this complaint, it has been determined that this sample functioned per specifications; therefore, no corrective action is required at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).

• Brand Name: VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT)
• Type of Device: TUBING, NONINVASIVE
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 7992492
• MDR Text Key: 124674638
• Report Number: 1644019-2018-00247
• Device Sequence Number: 1
• Product Code: GAZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 8065750957
• Device Lot Number: 2108641H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Initial Date Manufacturer Received: 09/28/2018
• Initial Date FDA Received: 10/22/2018
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM; SILIKON 1000 OIL
• Patient Age: 71 YR