BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPRAMID BLACK 3/0 (2) 75CM DS24

    MDR report key: 24427163 · Received February 24, 2026

    Report

    Report Number
    3003639970-2026-00163
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    February 11, 2026
    Report Date
    February 24, 2026
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAR
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. SUMMARY OF INVESTIGATION: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED A PICTURE SHOWING AN OPEN AND USED SAMPLE WITH THE NEEDLE ATTACHED TO THE THREAD BUT WITH THE THREAD'S COVERSHEET DAMAGED AND THE THREAD BROKEN. HOWEVER, 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 FULFILL B. BRAUN SURGICAL REQUIREMENTS. CONCLUSION ROOT CAUSE ANALYSIS: IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE BECAUSE NO SAMPLES HAVE BEEN RECEIVED, ONLY A PICTURE SHOWING AN OPEN AND USED SAMPLE. FINAL CONCLUSION: WITHOUT CLOSED SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFILL THE SPECIFICATIONS. IN SPITE OF THE FACT THAT WE HAVE RECEIVED A PICTURE, A PROPER ANALYSIS CANNOT BE PERFORMED AND THE CASE CANNOT BE CONFIRMED DUE TO LACK OF EVIDENCE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND, IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE CASE AND ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED, OUR ANALYSIS IS VERY LIMITED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH SUPRAMID SUTURE. THE CLIENT (VETERINARIAN) REPORTED A NEEDLE DETACHMENT BEFORE USE. MATERIAL SNAPPED OFF OR LET GO FROM NEEDLE-ATTACH. ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628819 SUPRAMID BLACK 3/0 (2) 75CM DS24 OTHER SUTURES GAR B. BRAUN SURGICAL, S.A. C0714356 625311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown