BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPRAMID BLACK 4/0 (1.5) 45CM HS15

    MDR report key: 21674943 · Received March 24, 2025

    Report

    Report Number
    3003639970-2025-00133
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Report Date
    March 24, 2025
    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 OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED 32 CLOSED SAMPLES AND 2 OPEN SAMPLES WITHOUT PACKAGE (ONE OF THEM WITH THE NEEDLE DETACHED FROM THE THREAD AND THE OTHER ONE WITH THE NEEDLE ATTACHED TO THE THREAD). NEEDLE ATTACHMENT STRENGTH RESULTS CONDUCTED ON THE CLOSED SAMPLES RECEIVED ARE 0.81 KGF IN AVERAGE AND 0.22 KGF IN MINIMUM. THE EUROPEAN PHARMACOPOEIA (EP) REQUIREMENTS ARE: 0.46 KGF IN AVERAGE AND 0.23 KGF IN MINIMUM. ONE OF THE CLOSED SAMPLES DOES NOT FULFIL THE MINIMUM, BUT 1 LOW VALUE IN 15 TESTED UNITS IS ACCEPTED, ACCORDING TO THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA. HOWEVER, TAKING INTO ACCOUNT THE OPEN SAMPLE RECEIVED WITH THE NEEDLE DETACHED FROM THE THREAD AND THE CLOSED SAMPLE ANALYZED THAT DOES NOT MEET THE MINIMUM, WE CONSIDER THIS COMPLAINT TO BE CONFIRMED. 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 SHOW THE NEEDLE ESCAPED FROM THE THREAD. FINAL CONCLUSION: CONSIDERING ONE OF THE OPEN SAMPLES RECEIVED THAT THE NEEDLE IS DETACHED FROM THE THREAD, AND ONE CLOSED SAMPLE THAT DOES NOT FULFILL THE MINIMUM OF THE SPECIFICATIONS OF THE EUROPEAN PHARMACOPOEIA, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE FAILURE IN THE SAMPLES RECEIVED. CORRECTIVE MEASURES: ACTIONS ON PRODUCT DISTRIBUTED 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 NEEDLE IS COMING LOOSE FROM THE THREAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738968 SUPRAMID BLACK 4/0 (1.5) 45CM HS15 OTHER SUTURES GAR B. BRAUN SURGICAL, S.A. C0712043 624124

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown