MAUDE Adverse Event Report: BIOSPHERE MEDICAL, S.A. BEARING NSPVA; AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS

Catalog Number	V100EP
Medical Device Problem Codes	Clumping in Device or Device Ingredient (1095); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was identified during internal quality system activities.Upon review, the manufacturer determined the event meets fda criteria for reporting.The report is being submitted to ensure accuracy and completeness of mdr files.This submission does not reflect a change in device performance or patient risk.The awareness date corresponds to when the manufacturer became aware of the event details.All information reasonably known to the manufacturer at this time has been included.The suspect device was not returned for evaluation.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Retention samples from the same batch are compliant.The powder has a compliant appearance and is not found in the cap.Many customers received this batch, which contains (b)(4) units, and only 2 indian customers sent a complaint.In some cases, the powder may remain in the area of the cap or on the inner wall of the vial.In such cases, gently tapping the vial will allow the powder to settle at the bottom of the vial.Because the device was not returned for analysis, it is not possible to fully perform the investigation of this complaint and provide cause of the reported issue.
Event or Problem Description
The customer reported that during preparation of bearing nspva, the operator found that the vial was empty.There was no patient injury.

• Brand Name: BEARING NSPVA
• Common Device Name: AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS
• Manufacturer (Section D): BIOSPHERE MEDICAL, S.A.; parc des nations paris nord 2; 383 rue de la belle etoile; roissy-en-france, 95700 ; FR 95700
• Manufacturer (Section G): BIOSPHERE MEDICAL S.A.; parc des nations paris nord 2; 383 rue de la belle etoile; roissy-en-france, 95700 ; FR 95700
• Manufacturer Contact: marie-laure patucca ; parc des nations paris nord 2; 383 rue de la belle etoile; roissy-en-france, 95700 ; FR 95700
• MDR Report Key: 24820066
• Report Number: 9615728-2026-00012
• Device Sequence Number: 21254367
• Product Code: NAJ
• UDI-Device Identifier: 00884450123317
• UDI-Public: 00884450123317
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K130259
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: V100EP
• Device Lot Number: X3167548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2025
• 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