BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN QUICK UNDY 5/0(1)70CM DS16(M)DDP

    MDR report key: 10223618 · Received July 2, 2020

    Report

    Report Number
    3003639970-2020-00229
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Report Date
    August 11, 2020
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: (B)(4). WE HAVE RECEIVED A PICTURE SHOWING A NEEDLE DETACHED FROM THE THREAD AND THE THREAD BROKEN IN SEVERAL PIECES. THIS PICTURE IS ALSO FOR ANOTHER COMPLAINT RECEIVED FROM THE SAME END CUSTOMER BUT DIFFERENT BATCH SO IT IS NOT CONFIRMED FOR WHICH COMPLAINT CORRESPOND THE PICTURE RECEIVED. AS THERE ARE UNITS IN STOCK, WE HAVE ANALYZED 15 CLOSED SAMPLES FROM THE STOCK. TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFILL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.68 KGF IN AVERAGE AND 0.57 KGF IN MINIMUM (EP REQUIREMENTS: 0.39 KGF IN AVERAGE AND 0.07 KGF IN MINIMUM). WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFILL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.38 KGF IN AVERAGE AND 0.23 KGF IN MINIMUM (EP REQUIREMENTS: 0.23 KGF IN AVERAGE AND 0.11 KGF IN MINIMUM). REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. MOREOVER THE RESULTS OF THE SAMPLES FROM STOCK 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. THE CASE IS CONSIDERED NOT CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. WE REGRET ANY INCONVENIENCE THIS ISSUE MAY HAVE CAUSED AND THANK YOU FOR YOUR COLLABORATION. 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.

    Additional Manufacturer Narrative · 1

    K170661. 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NOVOSYN QUICK UNDYED SUTURE. THE CLIENT REPORTED THAT THE THREAD BREAKS NEAR THE NEEDLE END. NO MORE DATA HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689936 NOVOSYN QUICK UNDY 5/0(1)70CM DS16(M)DDP SYNTHETIC ABSORBABLE BRAIDED S GAM B. BRAUN SURGICAL, S.A. C3046212 118216

    Patients

    Seq Age Sex Outcome Treatment
    1