BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 3/0 (2) 75CM DS24 (M)

    MDR report key: 5101375 · Received September 24, 2015

    Report

    Report Number
    2916714-2015-00833
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Report Date
    January 22, 2016
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    K980703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 5 UNOPENED RACEPACKS. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. (B)(4) UNITS WERE MANUFACTURED AND DISTRIBUTED OF THIS CODE BATCH, THERE ARE NO UNITS IN STOCK. TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLE RECEIVED AND THE RESULTS FULFILLS THE OEM REQUIREMENTS. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLS THE OEM REQUIREMENTS. AS INSTRUCTED FOR USE:"WHEN WORKING WITH SUTURE MATERIALS GREAT CARE SHOULD BE TAKEN TO ENSURE THAT THE USE OF SURGICAL INSTRUMENTS, SUCH AS TWEEZERS AND NEEDLE HOLDERS, DOES NOT CAUSE THE MATERIAL TO BE DAMAGED BY BEING PINCHED OR KINKED". FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. NOTE IS TAKEN OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. ACTIONS ON PRODUCT: NOT APPLICABLE. CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION ON GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THREAD BROKE DURING SURGERY. DURING A SKIN SUTURES WITH PREMILENE 3/0 DS 24 75CM, LOT 115195, THE SURGEON NOTED THAT WITH THIS SINGLE BOTTOM SUTURES THE THREAD IS RIPPING AND IT IS MORE BREAKING OF THE THREAD. ALSO, IT WAS NOTED BY THE SURGEON THAT DUE TO OPTICAL APPARENCY OF PREMILENE ( 3/0 SEEMS TO BE THINNER THAN PROLENE 3/0) THE CUSTOMER DECIDED TO USE PREMILENE 2/0. NEVERTHELESS, THE THREADS ARE BREAKING TOO EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632020 PREMILENE 3/0 (2) 75CM DS24 (M) SUTURES GAW B.BRAUN SURGICAL SA C2090235 115195

    Patients

    Seq Age Sex Outcome Treatment
    1 Other