BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOCRIN 4/0 (1.5) 75CM DS16

    MDR report key: 8637378 · Received May 23, 2019

    Report

    Report Number
    3003639970-2019-00413
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Report Date
    July 19, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAR
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES RECEIVED: THERE ARE NO SAMPLES OR BATCH NUMBER AVAILABLE FOR ANALYSIS. ANALYSIS AND RESULTS: AS NO BATCH NUMBER IS RECEIVED THE BATCH MANUFACTURING RECORD CANNOT BE REVIEWED. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS. WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. REMARKS: CARE SHOULD BE TAKEN TO AVOID DAMAGE WHEN HANDLING SURGICAL NEEDLES. GRASP THE NEEDLE IN AN AREA ONE THIRD (1/3) TO ONE HALF (1/2) OF THE DISTANCE FROM THE ATTACHMENT END TO THE POINT. GRASPING IN THE POINT AREA COULD IMPAIR THE PENETRATION PERFORMANCE AND CAUSE FRACTURE OF THE NEEDLE. GRASPING AT THE BUTT OR ATTACHMENT END COULD CAUSE BENDING OR BREAKAGE. 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. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE 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. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS 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. K990090 WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NEEDLE IS DAMAGED/BROKEN. THE REPORTER INDICATED THAT THE NEEDLE IS BROKEN. NO OTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430330 FLEXOCRIN 4/0 (1.5) 75CM DS16 OTHER SUTURE GAR B.BRAUN SURGICAL SA C0862223

    Patients

    Seq Age Sex Outcome Treatment
    1