BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 5/0 (1) 90CM 2XHR17 CV

    MDR report key: 8744364 · Received June 28, 2019

    Report

    Report Number
    3003639970-2019-00504
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    May 21, 2019
    Report Date
    June 28, 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 · 1

    (B)(4). 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. K980703. INVESTIGATION. SAMPLES RECEIVED: 2 UNOPENED RACEPACKS AND 1 OPENED. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 2,700 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED TWO CLOSED SAMPLES AND ONE OPEN AND USED SAMPLE WITH THE THREAD BROKEN. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.57 KGF IN AVERAGE AND 0.52 KGF IN MINIMUM (EP REQUIREMENTS: 0.23 KGF IN AVERAGE AND 0.11 KGF IN MINIMUM) WE HAVE ALSO TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.66 KGF IN AVERAGE AND 0.61 KGF IN MINIMUM (EP REQUIREMENTS: 0.31 KGF IN AVERAGE AND 0.10 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. REMARKS: WHEN WORKING WITH OPTILENE® SUTURE MATERIAL, GREAT CARE SHOULD BE TAKEN TO AVOID ANY CRUSHING OR CRIMPING DAMAGE OF THE MONOFILAMENT BY INSTRUMENTS SUCH AS FORCEPS OR NEEDLE HOLDERS. 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 · 1

    THE REPORTER INDICATED THAT THE THREAD BREAKS VERY EASY. THIS OCCURRED AT THE FEMORAL ANASTOMOSIS CREATING UNCERTAINTY IN THE SUTURE. NO PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536871 PREMILENE 5/0 (1) 90CM 2XHR17 CV CARDIAC SUTURE GAW B.BRAUN SURGICAL SA C2090901 116414V004

    Patients

    Seq Age Sex Outcome Treatment
    1