BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 9161195 · Received October 7, 2019

    Report

    Report Number
    3003639970-2019-00677
    Event Type
    Death
    Date Received
    October 7, 2019
    Report Date
    November 20, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    NEW
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLES RECEIVED: 12 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME REFERENCE-BATCH. (B)(4). THERE ARE NO UNITS IN OUR STOCK. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. WE HAVE RECEIVED 12 CLOSED SAMPLES FROM THE CUSTOMER. TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND ALL UNITS ARE TIGHT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF ALL SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 5.93 KGF IN AVERAGE AND 5.51 KGF IN MINIMUM (EP REQUIREMENTS: 5.18 KGF IN AVERAGE AND 2.59 KGF IN MINIMUM) DEGRADATION TEST RESULTS CONDUCTED ON THE SAMPLES RECEIVED FULFIL B. BRAUN SURGICAL REQUIREMENTS. IN THE DEGRADATION TEST, THREADS ARE INTRODUCED IN A SÖRENSEN BUFFER SOLUTION AT 37ºC FOR 28 DAYS. AFTER THIS PERIOD, THE KNOT PULL TENSILE STRENGTH OF THE THREAD IS TESTED. THE RESULTS FOR THE SAMPLES RECEIVED ARE 4.51 KGF IN AVERAGE AND 4.02 KGF IN MINIMUM (B. BRAUN SURGICAL REQUIREMENTS ARE 3.18 KGF IN AVERAGE AND 2.12 KGF IN MINIMUM). WE HAVE ALSO TESTED THE LINEAR STRAIGHT PULL TENSILE STRENGTH AFTER THIS PERIOD AND THE RESULTS CONDUCTED ON THE SAMPLES RECEIVED FULFIL THE BBS REQUIREMENT: 8.13 KGF IN AVERAGE AND 6.13 KGF IN MINIMUM (BBS REQUIREMENT: 3.71 KGF). WE HAVE ALSO CONDUCTED A REVIEW OF THE COMPLAINT HISTORY RECORD AND THERE ARE NO PREVIOUS COMPLAINTS IN THE PRODUCTS MANUFACTURED WITH THE SAME THREAD RAW MATERIAL BATCH AS THE INVOLVED CODE-BATCH. FINAL CONCLUSION: ACCORDING TO THE RESULTS OF THE SAMPLES TESTED AND THE BATCH MANUFACTURING RECORD REVIEW, THE PRODUCT COMPLIES WITH OUR SPECIFICATIONS AND ALSO FULFIL USP/EP REQUIREMENTS. THEREFORE, WE DO NOT SEE ANY MANUFACTURING FAULT OR MATERIAL DEFECT THAT COULD HAVE CAUSED THE INCIDENCE. 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

    ADDITIONAL INFORMATION WAS RECEIVED ON 11OCT2019: THE SURGEON CONFIMED ONE CASE OF A DEATH WITH ONE PATIENT; HOWEVER, STATES THAT THE ASSUMPTION IS BECAUSE OF BAD OVERALL HEALTH CONDITION OF THE PATIENT. PATIENT INFORMATION IS NOT AVAILABLE.

    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. K031216. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABDOMEN BURST. THE REPORTER INDICATED THAT 2 WEEKS SURGICAL POST-OPERATIVE; ABDOMINAL WOUND DEHISCENCE OCCURRED ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER HAS NOT YET BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955081 MONOPLUS VIOLET 1 (4) 150CM HRT48(M)LOOP SYNTHETIC ABSORBABLE MONOFILAR NEW B.BRAUN SURGICAL SA B0024393 118262V007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other