BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPRAMID BLACK 4/0 (1.5) 45CM DS16

    MDR report key: 24543816 · Received March 9, 2026

    Report

    Report Number
    3003639970-2026-00170
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Report Date
    April 13, 2026
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAR
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY OF INVESTIGATION: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED A PICTURE WITH AN OPEN AND MANIPULATED SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD. WITHOUT ANY CLOSED AND/OR DEFECTIVE SAMPLE, WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. BATCH MANUFACTURING RECORD: REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. CONCLUSION ROOT CAUSE ANALYSIS: IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE AS NO SAMPLES HAVE BEEN RECEIVED FOR ANALYSIS, ONLY A PICTURE. FINAL CONCLUSION: IN SPITE OF RECEIVING A PICTURE SHOWING A DEFECTIVE SAMPLES, WITHOUT CLOSED SAMPLES A SUITABLE ANALYSIS CANNOT BE PERFORMED, AND THE CASE IS CONSIDERED NOT CONFIRMED. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY CLOSED SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. CORRECTIVE MEASURES: ACTIONS ON DISTRIBUTED PRODUCT OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Additional Manufacturer Narrative · 0

    G4: REPORTED DEVICE NOT MARKETED IN THE U.S., 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 SUPRAMID SUTURE. THE CLIENT REPORTED THAT THREAD DETACHED FROM NEEDLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH SUPRAMID SUTURE. THE CLIENT REPORTED THAT THREAD DETACHED FROM NEEDLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197223 SUPRAMID BLACK 4/0 (1.5) 45CM DS16 OTHER SUTURES GAR B. BRAUN SURGICAL, S.A. C0712132 624261

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown