BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPRAMID BLACK 4/0 (1.5) 45CM DS19

    MDR report key: 24556675 · Received March 10, 2026

    Report

    Report Number
    3003639970-2026-00162
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    February 11, 2026
    Report Date
    March 10, 2026
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAR
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 91 CLOSED SAMPLES FOR ANALYSIS. TO EVALUATE THE CONFORMITY OF THESE UNITS, WE PERFORMED THE FOLLOWING TEST: - NEEDLE ATTACHMENT STRENGTH RESULTS CONDUCTED ON THE CLOSED SAMPLES RECEIVED ARE 1.01 KGF IN AVERAGE AND 0.01 KGF IN MINIMUM. THE RESULTS DO NOT FULFILL THE EUROPEAN PHARMACOPOEIA (EP) REQUIREMENTS FOR MINIMUM (EP REQUIREMENTS: 0.46 KGF IN AVERAGE AND 0.23 KGF IN MINIMUM). 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: THE MOST PROBABLE ROOT CAUSE IS THAT THE ATTACHMENT OF THE NEEDLE WAS NOT CORRECTLY DONE AS THE DEFECTIVE SAMPLES RECEIVED SHOW THAT THE NEEDLE IS ESCAPED FROM THE THREAD. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLES RECEIVED DO NOT FULFIL THE SPECIFICATIONS OF THE EUROPEAN PHARMACOPOEIA/B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED. 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 REPORTED THAT THE THREAD IS DETACHING FROM THE NEEDLE BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623743 SUPRAMID BLACK 4/0 (1.5) 45CM DS19 OTHER SUTURES GAR B. BRAUN SURGICAL, S.A. C0712205 625062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown