BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS VIOLET 3/0 (2) 20CM SKR26B (M)D

    MDR report key: 8750261 · Received July 1, 2019

    Report

    Report Number
    3003639970-2019-00510
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    May 21, 2019
    Report Date
    June 28, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    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

    PMA/510K: 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: 36 UNOPENED POUCHES AND 1 OPENED. FURTHERMORE, AN OPEN SAMPLE OF PDS II (ETHICON). ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 144 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 36 CLOSED SAMPLES AND 1 OPEN AND USED SAMPLE WITH THE THREAD BROKEN. WE HAVE ALSO RECEIVED ONE OPEN SAMPLE OF PDS II (FROM ETHICON). FOR FURTHER INFORMATION ABOUT PDS II SAMPLE, PLEASE CONTACT PRODUCT MANAGER DIRECTLY. TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF ALL CLOSED SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP):2.22 KGF IN AVERAGE AND 1.91 KGF IN MINIMUM (EP REQUIREMENTS: 1.81 KGF IN AVERAGE AND 0.91 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 MONOPLUS SUTURE MATERIALS GREAT CARE SHOULD BE TAKEN TO ENSURE THAT THE USE OF SURGICAL INSTRUMENTS, SUCH AS TWEEZERS AND NEEDLE HOLDERS, DOES NOT CAUSE THE MATERIAL TO BE DAMAGED BY BEING PINCHED OR KINKED. 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. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541676 MONOPLUS VIOLET 3/0 (2) 20CM SKR26B (M)D SYNTHETIC ABSORBABLE MONOFILAR GAM B.BRAUN SURGICAL SA C0024572 118111V004

    Patients

    Seq Age Sex Outcome Treatment
    1