BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 7/0 (0,5) 60CM 2XDR10 CV RCP

    MDR report key: 8811175 · Received July 22, 2019

    Report

    Report Number
    3003639970-2019-00545
    Event Type
    Malfunction
    Date Received
    July 22, 2019
    Date of Event
    June 22, 2019
    Report Date
    July 31, 2019
    Manufacturer
    B/ BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING EVALUATION - ANALYSIS AND RESULTS: THERE IS ONE PREVIOUS COMPLAINT OF THIS CODE-BATCH REGARDING OTHER ISSUE. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 72 CLOSED SAMPLES FOR ANALYSIS. WE HAVE CHECKED ALL SAMPLES RECEIVED AND WE HAVE FOUND ONE OF THEM WITH ONE OF THE NEEDLES ALREADY DETACHED FROM THE THREAD. WE HAVE ALSO TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE SAMPLES RECEIVED AND WE HAVE FOUND VALUES THAT DO NOT FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP). ON THE OTHER HAND, WE HAVE FOUND SPLITTING NEAR THE NEEDLE ATTACHMENT IN SOME OF THE TESTED SAMPLES, PROBABLY BY AN EXCESS STRENGTH APPLIED TO ATTACH THE THREAD TO THE NEEDLE. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLES RECEIVED DO NOT FULFIL THE SPECIFICATIONS OF THE EUROPEAN PHARMACOPOEIA/B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED.

    Additional Manufacturer Narrative · 1

    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., K133890. WHEN ADDITIONAL INFORMATION HAS BEEN RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NEEDLE DETACHED FROM THE THREAD.. THE DEFECT WAS FOUND BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604371 OPTILENE 7/0 (0,5) 60CM 2XDR10 CV RCP CARDIAC SUTURE GAW B/ BRAUN SURGICAL SA C3090714 114511

    Patients

    Seq Age Sex Outcome Treatment
    1