BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOCRIN 6/0 (0.7) 60CM DS9

    MDR report key: 8672362 · Received June 5, 2019

    Report

    Report Number
    3003639970-2019-00451
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Date of Event
    March 19, 2019
    Report Date
    June 5, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAR
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. 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. K990090. INVESTIGATION: SAMPLES RECEIVED: (B)(4) UNOPENED POUCHES AND ONE NEEDLE WITHOUT PACKAGING (NEITHER THREAD). ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME 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 (B)(4) CLOSED SAMPLES AND A DETACHED NEEDLE (USED). WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE 20 CLOSED SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP):0.28 KGF IN AVERAGE AND 0.218 KGF IN MINIMUM (EP REQUIREMENTS: 0.17 KGF IN AVERAGE AND 0.082 KGF IN MINIMUM). 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. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE CLOSED SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. 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. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NEEDLE DETACHED. THE REPORTER INDICATED THAT THE NEEDLE BECAME DETACHED FROM THE THREAD. NO OTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463719 FLEXOCRIN 6/0 (0.7) 60CM DS9 OTHER SUTURE GAR B.BRAUN SURGICAL SA C0865800 617507V006

    Patients

    Seq Age Sex Outcome Treatment
    1