MAUDE Adverse Event Report: VITREQ B.V. 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	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the investigation conclusions.
Event or Problem Description
On october 16th, 2025, bvi vitreq was informed about an issue concerning our product, bf25.D02.As stated by the customer, and voluntarily reported to the ansm, during insertion into the vitrectomy trocar, the silicone tip detached inside the eye.Of the three units used during two separate procedures (same batch number), two exhibited the same issue.The incident resulted in a prolongation of the operating time.Additionally, the customer expressed concern about a potential risk of leaving a piece of transparent silicone inside the eye if it goes unnoticed by the surgeon.The risk related to detachment of a silicone tip for a backflush device is covered in our risk management files.The other procedure is reported under a separate emdr report #3012037425-2025-00004.
Additional Manufacturer Narrative
Vitreq b.V.Has investigated the complaint in accordance with the established internal procedure.Based on the additional information gathered, the device used during this incident has been discarded at the customer.Nevertheless, unused samples from the same lot were returned and investigated.The visual inspection performed showed that all silicone tip incisions were normal, no deviations were found.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 B.V.; seggelant-noord 2; vierpolders, zuid-holland 3237 MG; NL 3237 MG
• Manufacturer (Section G): VITREQ B.V.; 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: 23498456
• Report Number: 3012037425-2025-00003
• Device Sequence Number: 9038001
• Product Code: HMX
• UDI-Device Identifier: 88719214220910
• UDI-Public: (01)88719214220910
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: 20259055R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2025
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown