BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICRON GREEN 2/0 (3) 75CM HR26 (M)

    MDR report key: 8745908 · Received June 28, 2019

    Report

    Report Number
    3003639970-2019-00511
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    May 29, 2019
    Report Date
    July 1, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: G5: 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. K012201.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. SAMPLES RECEIVED: 28 UNOPENED RACE PACKS. ANALYSIS AND RESULTS: THERE ARE TWO PREVIOUS COMPLAINTS OF THIS CODE-BATCH, ONE REGARDING THE SAME ISSUE. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 1.9 KGF IN AVERAGE AND 1.02 KGF IN MINIMUM (EP REQUIREMENTS: 0.51 KGF IN AVERAGE AND 0.15 KGF IN MINIMUM) WE HAVE NOT FOUND SPLITTING ON THE THREAD SURFACE ON THE CLOSED SAMPLES RECEIVED BEFORE AND AFTER PERFORMING THIS TEST. ADDITIONALLY, WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 1.53 KGF IN AVERAGE AND 1.19 KGF IN MINIMUM (EP REQUIREMENTS: 0.46 KGF IN AVERAGE AND 0.23 KGF IN MINIMUM) HOWEVER, WE HAVE FOUND SPLITTING ON THREAD SURFACE IN SOME SAMPLES RECEIVED DURING PERFORMING NEEDLE ATTACHMENT TEST. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLES RECEIVED DO NOT FULFIL THE SPECIFICATIONS OF THE EUROPEAN PHARMACOPEIA/B.BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE THREAD BROKE AND SPLICED. THE REPORTER INDICATED THAT THE THREAD BROKE AND "SPLICED" EASILY. NO PATIENT INFORMATION OR TYPE OF SURGICAL PROCEDURE HAS BEEN PROVIDED. PATIENT OUTCOME WAS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537399 PREMICRON GREEN 2/0 (3) 75CM HR26 (M) OPTILENE NON-CARDIOVASCULAR GAW B.BRAUN SURGICAL SA C0026016

    Patients

    Seq Age Sex Outcome Treatment
    1