BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL UNDYED 5/0 (1) 70CM HR17 (M)

    MDR report key: 9159989 · Received October 5, 2019

    Report

    Report Number
    3003639970-2019-00680
    Event Type
    Malfunction
    Date Received
    October 5, 2019
    Date of Event
    September 16, 2019
    Report Date
    January 3, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    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 · 0

    SAMPLES RECEIVED: NONE. 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 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 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 · 1

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, (B)(4) MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K980704. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE DETACHMENT. THE REPORTER INDICATED THAT THE NEEDLE IS PERMANENTLY TEARING FROM THE THREAD. PER THE REPORTER, "SUCH PRODUCT DOESN T MEET REQUIREMENTS OF PRODUCT SAFETY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953769 SAFIL UNDYED 5/0 (1) 70CM HR17 (M) SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA C1049012

    Patients

    Seq Age Sex Outcome Treatment
    1