BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NY-STA BLACK 2/0 18" (45CM) DS24 VPL

    MDR report key: 25078020 · Received May 5, 2026

    Report

    Report Number
    3003639970-2026-00431
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Report Date
    May 5, 2026
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAR
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: REPORTED DEVICE MARKETED IN THE U.S. ONLY FOR VETERINARY USE, HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. RELATED 510K NUMBER K151165. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH NY-STA BLACK SUTURE. THE CLIENT (VETERINARIAN) REPORTED THAT THE NEEDLES ARE DULL AND NOT USEABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555737 NY-STA BLACK 2/0 18" (45CM) DS24 VPL OTHER SUTURES GAR B. BRAUN SURGICAL, S.A. 30022 623302

    Patients

    Seq Age Sex Outcome Treatment
    1