BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL QUI+ UNDY 2/0 (3) 90CM HRT37(M)

    MDR report key: 5515362 · Received March 21, 2016

    Report

    Report Number
    2916714-2016-00209
    Event Type
    Malfunction
    Date Received
    March 21, 2016
    Report Date
    March 21, 2016
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    K031286
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018 MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING

    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: SAMPLES RECEIVED: 3 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME REFERENCE BATCH. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH (B)(4) UNITS WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET. THERE ARE NO UNITS IN STOCK. TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLE RECEIVED AND THE RESULTS FULFILLS THE OEM REQUIREMENTS. DEGRADATION TEST (7 DAYS IN 0.9 % NACL SOLUTION AT 37ºC) HAS BEEN CONDUCTED WITH THE SAMPLES RECEIVED AND THE RESULTS FULFILL (B)(4) SURGICAL REQUIREMENTS. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLS THE OEM REQUIREMENTS. AS INDICATED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT: "ABSORPTION (OF SAFIL QUICK) BEGINS AS A DECLINE IN THE TENSILE STRENGTH FOLLOWED BY A LOSS OF MASS. SUBCUTANEOUS AND INTRAMUSCULAR IMPLANTATION STUDIES OF SAFIL QUICK SHOW THAT AT 5 DAYS POST-IMPLANTATION APPROXIMATELY 50% OF THE INITIAL TENSILE STRENGTH REMAINS AND 10 TO 14 DAYS POST-IMPLANTATION ALMOST ALL OF THE INITIAL TENSILE STRENGTH IS LOST.". USAGE OF SAFIL QUICK MAY NOT BE ADVISED IN CASE OF ELDERLY, MALNOURISHED OR DEBILITATED PATIENTS, OR IN PATIENTS SUFFERING FROM DISEASES OR CONDITIONS WHICH DELAY THE WOUND HEALING PROCESS. FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFILLS THE OEM REQUIREMENTS, NOTE IS TAKEN OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. ACTIONS ON PRODUCT: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO TAKE AN ACTION ON DISTRIBUTED PRODUCT. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO THE INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). SUTURE LINES WERE BREAKING UP DURING KNOTTING AND SUTURING BY DIFFERENT SURGEONS AT ONE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169440 SAFIL QUI+ UNDY 2/0 (3) 90CM HRT37(M) SUTURES GAM B.BRAUN SURGICAL SA C1046651 114417

    Patients

    Seq Age Sex Outcome Treatment
    1