MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA CUSTOM TDC VITRECTOMY PACK VGPC INPUT 23G; SURGICAL PACKS AND KITS

Model Number 8523.410

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

It was reported that when the doctor inserted the infusion line it started to leak.The leakage continued throughout the "peel" phase.No action was taken and procedure was continued.No patient injury occurred.

Manufacturer Narrative

With regards to this complaint, a standard infusion line and a cannula with closure valve were received for investigation.Microscopic examination revealed a small tear in the closure valve.No obstructions were detected.Despite the observed tear, the product was subject to functional testing.Testing in accordance with the applicable product specification at a pressure of 40 mmhg revealed that the maximum allowed leakage was not exceeded, not even when the pressure was raised to 80 mmhg.The only way to reproduce leakage as reflected on the picture provided with the reported event was to perform the test with an obstructed cannula.Device history record review revealed no deviations and a database search showed that no similar complaints have been reported on this specific lot previously.Based upon the investigation performed it is concluded that the infusion line meets the product specification.The small tear observed in the closure valve did not impact performance.Cause of the tear has not been identified but could be attributable to an unintended use error when inserting the infusion line.Taking into account the fact that the leakage from the infusion line was within the leakage specifications, this reported event is considered not reportable taking into account the results of the investigation performed.The risk identified is included in the risk management documentation.Trend analysis indicates that the product is performing within anticipated rates.Therefore, no remedial or corrective/preventive actions will be undertaken at this moment.Complaints will be closely monitored to identify any significant adverse trends.

Event Description

It was reported that when the doctor inserted the infusion line it started to leak.The leakage continued throughout the "peel" phase.No action was taken and procedure was continued.No patient injury occurred.

• Brand Name: EVA CUSTOM TDC VITRECTOMY PACK VGPC INPUT 23G
• Type of Device: SURGICAL PACKS AND KITS
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuidland, ; NL
• MDR Report Key: 11252946
• MDR Text Key: 230743210
• Report Number: 1222074-2021-00007
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup

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: No Information
• Device Model Number: 8523.410
• Device Catalogue Number: 8523.410
• Device Lot Number: 2000414395
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/11/2021
• Patient Sequence Number: 1