BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMAX VIOLET 1(4)150CM HRT48 LOOP(M

    MDR report key: 8668583 · Received June 4, 2019

    Report

    Report Number
    3003639970-2019-00454
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Report Date
    June 4, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    NWJ
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. K100876. INVESTIGATION: SAMPLES RECEIVED: (B)(4) CLOSED SAMPLES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. WE HAVE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED (B)(4) CLOSED UNITS. TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFILL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP):5.86 KGF IN AVERAGE AND 4.80 KGF IN MINIMUM (EP REQUIREMENTS: 5.18 KGF IN AVERAGE AND 2.59 KGF IN MINIMUM). 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. REMARKS: AS INDICATED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT: "WHEN WORKING WITH MONOMAX® SUTURE MATERIALS GREAT CARE SHOULD BE TAKEN TO ENSURE THAT THE USE OF SURGICAL INSTRUMENTS, SUCH AS FORCEPS AND NEEDLE HOLDERS, DO NOT CAUSE ANY CRUSHING OR CRIMPING DAMAGE TO THE SUTURE MATERIAL". FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE THREAD BROKE INTRA-OPERATIVELY. THE REPORTER INDICATED THAT THE THREAD (SUTURE) BROKE DURING SUTURING IN TWO DIFFERENT SURGICAL PROCEDURES (TWO DIFFERENT PATIENTS) DURING CLOSURE OF THE ABDOMEN. THE OPERATING ROOM PERSONNEL HAS BEEN USING MONOMAX FOR A LONG TIME AND WHEN TRYING TO REPRODUCE THE PROBLEM IN PRESENCE OF THE SALES REP, NO PROBLEM COULD BE DETECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NOT YET RECEIVED. THIS REPORT IS FOR THE SECOND PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461221 MONOMAX VIOLET 1(4)150CM HRT48 LOOP(M SYNTHETIC ABSORBABLE MONOFILAR NWJ B.BRAUN SURGICAL SA B0041222 118516

    Patients

    Seq Age Sex Outcome Treatment
    1