BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 8/0 (0,4) 60CM 2XDR8F CV RCP

    MDR report key: 9802650 · Received March 6, 2020

    Report

    Report Number
    3003639970-2020-00127
    Event Type
    Malfunction
    Date Received
    March 6, 2020
    Date of Event
    February 12, 2020
    Report Date
    March 6, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    K133890 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. ANALYSIS AND RESULTS: AS NO BATCH NUMBER IS AVAILABLE, THE BATCH MANUFACTURING RECORD CANNOT BE REVIEWED. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS. WITHOUT ANY SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. 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. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH OPTILENE. THE CUSTOMER REPORTED BAD "NEEDLE-SUTURE". NEEDLE IS PERMANENTLY TEARING FROM THE THREAD. THERE IS NO PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265090 OPTILENE 8/0 (0,4) 60CM 2XDR8F CV RCP CARDIAC SUTURE GAW B.BRAUN SURGICAL SA C3090105

    Patients

    Seq Age Sex Outcome Treatment
    1