BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMAX VIOILET 0 (3.5) 150CM HR26S (M) DDP

    MDR report key: 3970157 · Received April 29, 2014

    Report

    Report Number
    2916714-2014-00310
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 29, 2014
    Manufacturer
    B BRAUN SURGICAL S.A.
    Product Code
    NWJ
    PMA / PMN Number
    K100876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVAL: SAMPLES RECEIVED: 2 UNOPENED AND 1 OPEN POUCH. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OEM STOCK. WIRE SIZE OF THE SAMPLES RECEIVED IS 0.98 MM, ACCORDING TO THE DESIGN WHEN THIS MATCH WAS MADE. THE CURRENT TABLE CORRESPONDENCES BETWEEN USP SIZE AND WIRE SIZE OF NEEDLES HAS BEEN CHECKED, AND THIS IS THE CORRESPONDING NEEDLE STRUCTURE. THE RATIO NEEDLE THREAD IS THE CORRECT ONE FOR THIS ARTICLE-CODE. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. THIS COMPLAINT IS NOT JUSTIFIED, ACCORDING TO THE MARKETING DESIGN OF THE ARTICLE. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTIONS ON PRODUCT: NOT APPLICABLE. CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE HEAD PHYSICIAN DOESN'T LIKE THE ARMORING. THE SIZE OF THE THREAD IS MUCH SMALLER AS THE NEEDLE SIZE. DUE TO THIS DIFFERENCE, THE PUNCTURE HOLE WOULDN'T BE FILLED OUT WITH THE THREAD AND THERE IS THE POSSIBILITY OF A RIP OF THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255571 MONOMAX VIOILET 0 (3.5) 150CM HR26S (M) DDP SYNTHETIC ABSORBABLE SUTURE NWJ B BRAUN SURGICAL S.A. B0041442 114043V004

    Patients

    Seq Age Sex Outcome Treatment
    1