MAUDE Adverse Event Report: VITREQ BV VITREQ; 25G BRUSH BACKFLUSH INSTRUMENT

Model Number	BF25.D02
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 01oct2025, we were notified that the "tip came off during use in surgery" for a bf25.D02 backflush device.Hospital was contacted to request follow-up information for the device where the tip came off.As far as bvi is currently aware there is no patient impact, the most likely scenario is that the surgeon immediately noticed that the tip came off and had removed the tip remains from the eye as part of the ongoing procedure.Although none of the information received to date point that harm occurred, the failure mode has the potential to cause serious injury if it recurs.Therefore, the event is considered reportable to the competent authorities as a device malfunction.
Additional Manufacturer Narrative
Returned device investigation showed traces of use as some residual liquid was observed.Tip was indeed found to be cut off, clear cutting marks are visible and no glue bond issues were identified as the silicone tip remains were found to be attached to the capillary still.It is thus confirmed that the tip must have come off during trocar handling.Flushing the device with water showed normal functionality and no leaks were observed and thereby ruling out a manufacturing error.Such a scenario is covered in the device's risk management files.Damage or deformation to a silicone-tipped instrument is oftentimes caused by instrument handling.When the device is inserted through a valved trocar, the fragile silicone tip may get damaged and this is inherent to the design characteristics of these instruments.Bvi vitreq had included a warning in the instructions for use to inform users about this potential failure which is stating "carefully insert the instrument into the cannula, too much friction may cause delicate parts to separate.Always check the instrument on damage during and after surgery." the complaint has been formally acknowledged and recorded in bvi's complaint management system.Bvi will continue to monitor customer feedback and will take appropriate action should any unfavorable trend be observed.
Additional Manufacturer Narrative
Vitreq b.V.Has investigated the complaint in accordance with the established internal procedure.In addition to the information provided in this section with the initial emdr, the production records of the involved lot were reviewed and no anomalies were found in relation to the investigated failure.Based on that we could exclude a manufacturing deficiency related to the product in question and concluded the failure mode is inherent to the design of soft-tipped devices and an ifu warning is in place "carefully insert the instrument into the cannula, too much friction may cause delicate parts to separate.Always check the instrument on damage during and after surgery." and therefore, this event is classified as user handling.No corrective or preventive actions are deemed necessary.Vitreq will continue to monitor any feedback from our customers and take appropriate action if unfavourable trends are observed.

• Brand Name: VITREQ
• Common Device Name: 25G BRUSH BACKFLUSH INSTRUMENT
• Manufacturer (Section D): VITREQ BV; seggelant-noord 2; vierpolders, zuid-holland 3237 MG; NL 3237 MG
• Manufacturer (Section G): VITREQ BV; seggelant-noord 2; vierpolders, zuid-holland 3237 MG; NL 3237 MG
• Manufacturer Contact: christian neele ; seggelant-noord 2; vierpolders, zuid-holland 3237 -MG ; NL 3237 MG
• MDR Report Key: 23411510
• Report Number: 3012037425-2025-00001
• Device Sequence Number: 9085022
• Product Code: HMX
• UDI-Device Identifier: 88719214220910
• UDI-Public: (01)88719214220910
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: Health Professional
• Device Model Number: BF25.D02
• Device Catalogue Number: N/A
• Device Lot Number: 20245410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown