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	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, bvi vitreq was informed of an issue concerning our product, bf25.D02.According to the customer, the silicone tip was found to be missing prior to use during the procedure.At that time, the complaint was considered not reportable, and a product return was initiated.After the product was received and evaluated, it was concluded that, contrary to the initial allegation, the backflush was most likely used during surgery and that the tip detached at some point during the procedure.As far as bvi is currently aware, there was no patient impact.The most likely scenario is that the surgeon immediately noticed that the tip had detached and removed the tip remnants from the eye as part of the ongoing procedure.Although none of the information received to date indicates 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
Additional information will be provided following the investigation conclusions.
Additional Manufacturer Narrative
Vitreq b.V.Has investigated the complaint in accordance with the established internal procedure.The lot no.Was unknown and therefore no investigation could be completed regarding the batch record.Vitreq does perform a 100% qc control where the tip is inspected for all backflushes.Based on that we could exclude a manufacturing deficiency related to the product.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 information on whether the tip remains have been removed from the eye was obtained.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 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: 24129935
• Report Number: 3012037425-2026-00002
• Device Sequence Number: 10387536
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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 Model Number: BF25.D02
• Device Catalogue Number: N/A
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown