BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 1 (4) 8X45CM HRB37STO(M)

    MDR report key: 5777457 · Received July 7, 2016

    Report

    Report Number
    2916714-2016-00532
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Date of Event
    June 2, 2016
    Report Date
    July 7, 2016
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: NO SAMPLES, TWO POSSIBLE BATCHES: 112424 AND 115352. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF ANY OF THE TWO POSSIBLE BATCHES. (B)(4) UNITS WERE MANUFACTURED OF BATCH 112424 AND (B)(4) UNITS OF BATCH 115352. THERE ARE NO UNITS IN STOCK OF ANY OF THE TWO BATCHES. WITHOUT ANY CLOSED SAMPLE AN ANALYSIS CANNOT BE CARRIED OUT IN ORDER TO MAKE A DECISION. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL THE OEM REQUIREMENTS. NEEDLE ATTACHMENT RESULTS CONDUCTED ON SAMPLES OF 112424 BATCH BEFORE RELEASING THE PRODUCT WERE 0.318 KGF IN MINIMUM AND 0.666 KGF IN MAXIMUM AND FULFILLED THE OEM SPECIFICATIONS OF 0.080 IN MINIMUM AND 1.700 KGF IN MAXIMUM. FINAL CONCLUSION: WITHOUT SAMPLES A STUDY CAN NOT BE PERFORMED TO SEE IF THE AFFECTED PRODUCT DOES NOT FULFILL THE OEM REQUIREMENTS. NOTE IS TAKEN OF THIS INCIDENCE AND IF ANY SAMPLES ARE RECEIVED IN THE FUTURE, THE CASE WILL BE RE-OPENED AND ANALYZED. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED ANALYZING IS VERY LIMITED. 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 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: JAPAN. THE NEEDLE OF THIS PRODUCT WAS DIFFICULT TO DETACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428751 MONOSYN VIOLET 1 (4) 8X45CM HRB37STO(M) SUTURES GAM B.BRAUN SURGICAL SA M0022891

    Patients

    Seq Age Sex Outcome Treatment
    1 Other