BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 5/0 (1) 70CM HR13 (M).RCP

    MDR report key: 8522471 · Received April 17, 2019

    Report

    Report Number
    3003639970-2019-00354
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Report Date
    May 24, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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. INVESTIGATION: SAMPLES RECEIVED: 1 OPENED. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. WE MANUFACTURED AND DISTRIBUTED (B)(4) UNITS OF THIS CODE BATCH, THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED ONE OPEN SAMPLE (IT SEEMS UNUSED) WITHOUT NEEDLE ATTACHED TO THREAD (THREAD IS NOT WOUND ON THE PACK). WE HAVE RECEIVED ONE OPEN SAMPLE (IT SEEMS UNUSED) WITHOUT NEEDLE ATTACHED TO THREAD (THREAD IS NOT WOUND ON THE PACK). HOWEVER, WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. A REVIEW OF THE BATCH MANUFACTURING RECORD FOR THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. NEEDLE ATTACHMENT STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE 0.83 KGF IN AVERAGE AND 0.54 KGF IN MINIMUM AND FULFILLED THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP REQUIREMENTS: 0.23 KGF IN AVERAGE AND 0.11 KFD IN MINIMUM). FINAL CONCLUSION: IN SPITE OF RECEIVING A DEFECTIVE SAMPLE, WITHOUT CLOSED SAMPLES A SUITABLE ANALYSIS CANNOT BE PERFORMED. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY CLOSED SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT. 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.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012 IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NEEDLE AND THREAD BECAME DETACHED INTRAOPERATIVELY. THE REPORTER INDICATED THAT WHEN OPENING THE SINGLE ENVELOPE THE THREAD (SUTURE) FELL TO THE FLOOR AND THE NEEDLE STAYED IN THE ENVELOPE. A SECOND SINGLE ENVELOPE WAS OPENED (FROM THE SAME PACKING AND SAME BATCH) AND THIS TIME THE NEEDLE FELL TO THE FLOOR AND THE THREAD (SUTURE) REMAINED IN THE ENVELOPE. ALL OTHER ENVELOPES WORKED WITHOUT PROBLEMS. NO PATIENT INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317880 MONOSYN VIOLET 5/0 (1) 70CM HR13 (M).RCP SYNTHETIC ABSORBABLE MONOFILAR GAM B.BRAUN SURGICAL SA C2022008 118165

    Patients

    Seq Age Sex Outcome Treatment
    1