BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 2/0 (3) 75CM GS60 (M) POW

    MDR report key: 6266500 · Received January 20, 2017

    Report

    Report Number
    3003639970-2017-00034
    Event Type
    Malfunction
    Date Received
    January 20, 2017
    Report Date
    March 20, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE THAT IS REGISTERED WITHIN THE U.S. AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THE NEEDLE DETACHED REPEATEDLY WHEN THE SKIN CLOSURE WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    RECEIVED SAMPLES: 3 UNUSED SUTURES, PREMILENE 2/0 GS 60, IN OPENED PACKAGE. PRELIMINARY ANALYSIS: STOCK REVIEW: ONCE THE STOCK OF THIS BATCH IN WAREHOUSE WAS REVIEWED, IT WAS VERIFIED THAT CURRENTLY THERE ARE NO UNITS OF THIS CODE AND BATCH NUMBER. IMPORTED/MANUFACTURED UNITS: 1.260 UNITS OF THIS CODE AND BATCH NUMBER WERE MANUFACTURED. DISTRIBUTED QUANTITY: ALL MANUFACTURED UNITS WERE DISTRIBUTED TO 12 CUSTOMERS, WHICH ARE LOCATED IN THE FOLLOWING CITIES: (B)(6). BACKGROUND: OUR COMPLAINT DATABASE WAS CHECKED, AND IT WAS IDENTIFIED THAT TO THE DATE, THERE AREN'T ANY REPORTS RELATED TO THIS PRODUCT CODE AND BATCH NUMBER, BY DIFFERENT CAUSE. BATCH RECORD: DOCUMENTATION REGARDING TO MANUFACTURING BATCH PROCESS WAS REVIEWED, VERIFYING IN PROCESS AND FINISHED PRODUCT QUALITY CONTROLS AND THERE WEREN'T FOUND DEVIATIONS, OR ALTERATIONS DURING PROCESS. RESULTS FOR BATCH RELEASE: REGARDING TO THE ESSAY OF RESISTANCE TO ATTACH IN THE BATCH RELEASE RECORD, THE TEST MET THE USP AND B.BRAUN MEDICAL REQUIREMENTS FOR THIS TYPE OF SUTURE. RESULTS FOR BATCH RELEASE: THE OBTAINED RESULTS FOR BATCH RELEASING, REGARDING TO RESISTANCE TO ATTACH, MET THE REQUIREMENTS FOR THIS TYPE OF SUTURE, WITH THE MINIMUM: 1.13 KGF., MAXIMUM 2.96 KGF., MEAN: 1.95 KGF (USP MEAN LIMIT: 1.10 KGF., INDIVIDUAL MINIMUM: 0.45 KGF). SAMPLE ANALYSIS: 3 OPENED, UNUSED SAMPLES WERE RECEIVED. SAMPLES HAVE THE NEEDLE DETACHED FROM THREAD AND THREAD IS COILED INTO PACKAGE. OBSERVATION: IF THIS PROBLEM CONTINUES, PLEASE PROVIDE 5 UNITS OF SAME BATCH IN ORDER TO PERFORM THE APPROPRIATE INVESTIGATION. CONCLUSIONS: TAKING INTO ACCOUNT THAT WE HAVEN'T RECEIVED OTHER COMPLAINTS FOR THIS CODE, BATCH AND CAUSE, IN SPITE OF OBTAINED RESULTS FOR BATCH RELEASING MEETING ALL SPECIFICATIONS, THIS COMPLAINT WAS CLASSIFIED AS "JUSTIFIED", INSOMUCH AS SAMPLES PROVIDED BY CUSTOMER DON'T MEET USP REQUIREMENTS AND B.BRAUN SPECIFICATIONS. ACTIONS: NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN ON THIS COMPLAINT. IT WILL BE INCLUDED IN THE TREND ANALYSIS OF THIS PRODUCT LINE AND CORRECTIVE ACTION WILL BE STARTED IF THE PROBLEM CONTINUES. PLEASE NOTE THAT THE FOLLOW UP MDR DATED 03/20/2017 HAD THE INCORRECT MEDWATCH NUMBER 3003669970-2017-00034. PER REQUEST OF THE FDA THE FOLLOW UP HAS BEEN CORRECTED AND RE-SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51383 PREMILENE 2/0 (3) 75CM GS60 (M) POW SUTURES GAW B.BRAUN SURGICAL SA C0095296 514491

    Patients

    Seq Age Sex Outcome Treatment
    1 Other