BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 2/0 (3) 70CM HS26 (M)

    MDR report key: 7534341 · Received May 22, 2018

    Report

    Report Number
    3003639970-2018-00319
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    March 23, 2018
    Report Date
    June 14, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING ADDITIONAL INFORMATION: H - 10: THIS REPORT IS BEING SUBMITTED LATE DUE TO MIS-INTERPRETATION OF 2 YEAR PRESUMPTION ACKONWLEDGEMENT AND AGREEMENT BY FDA. ONCE ISSUE WAS IDENTIFIED, RETROSPECTIVE REVIEW OF COMPLAINTS WAS COMPLETED FROM TIME OF 2 YEAR PRESUMPTION IMPLEMENTATION TO PRESENT. ALL REORTS IDENTIFIED ARE BEING REPORTED. H3 OTHER TEXT : DEVICE NOT RETURNED

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: SPAIN. WOUND DEHISCENCE: SIMPLE STITCHES OPENED

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: NONE. ANALYSIS AND RESULTS: THERE IS ONE PREVIOUS COMPLAINT OF THIS CODE-BATCH FROM THE SAME END CUSTOMER. WE HAVE RECEIVED THREE CASES MORE THE SAME DAY FROM THE SAME END CUSTOMER REGARDING THE SAME ISSUE. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS. HOWEVER, DEGRADATION TEST (14 DAYS IN SÖRENSEN SOLUTION AT 37ºC) WAS CONDUCTED WITH THE SAMPLES RECEIVED IN THE PREVIOUS COMPLAINT AND THE RESULTS FULFILLED B. BRAUN SURGICAL REQUIREMENTS (> 0.60 KGF). RESULTS: 2.80 KGF IN AVERAGE AND 2.28 KGF IN MINIMUM. FURTHERMORE, TIGHTNESS TEST TO THE SAMPLES RECEIVED WAS PERFORMED AND THE UNITS WERE TIGHT. 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: ALTHOUGH WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS, THE RESULTS OF THE SAMPLES TESTED OF THE SAME CODE-BATCH IN THE PREVIOUS COMPLAINT FROM THE SAME END CUSTOMER FULFILLED THE B. BRAUN SURGICAL SPECIFICATIONS. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374007 MONOSYN VIOLET 2/0 (3) 70CM HS26 (M) SUTURES GAM B.BRAUN SURGICAL SA C0022237 117381

    Patients

    Seq Age Sex Outcome Treatment
    1 Other