BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 0 (3.5) 70CM HR26 (M)

    MDR report key: 6305908 · Received February 6, 2017

    Report

    Report Number
    3003639970-2017-00051
    Event Type
    Malfunction
    Date Received
    February 6, 2017
    Date of Event
    January 9, 2017
    Report Date
    March 22, 2017
    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.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT DURING THREE DIFFERENT SURGERIES PERFORMED ON DOGS THE WOUND DEHISCENCE.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 5 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS BATCH. MANUFACTURED AND DISTRIBUTED (B)(4) UNITS OF THIS BATCH. THERE ARE NO UNITS IN STOCK. RECEIVED FIVE CLOSED SAMPLES. TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL REQUIREMENTS: 5.07 KGF IN AVERAGE AND 4.71 KGF IN MINIMUM. DEGRADATION TEST (14 DAYS IN SÖRENSEN SOLUTION AT 37ºC) HAS BEEN CONDUCTED WITH THE SAMPLES RECEIVED AND THE SAMPLES OF STOCK AND THE RESULTS FULFILL B. BRAUN SURGICAL REQUIREMENTS (> 0.88 KGF) RESULTS: 2.96 KGF IN AVERAGE AND 2.18 KGF IN MINIMUM. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL B.BRAUN SURGICAL REQUIREMENTS. REMARKS: AS INDICATED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT: "WHEN WORKING WITH MONOSYN® SUTURE MATERIALS GREAT CARE SHOULD BE TAKEN TO ENSURE THAT THE USE OF SURGICAL INSTRUMENTS, SUCH AS TWEEZERS AND NEEDLE HOLDERS, DOES NOT CAUSE THE MATERIAL TO BE DAMAGED BY BEING PINCHED OR KINKED." 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. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO 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
    87395 MONOSYN VIOLET 0 (3.5) 70CM HR26 (M) SUTURES GAM B.BRAUN SURGICAL SA G0022027 115481

    Patients

    Seq Age Sex Outcome Treatment
    1 Other