BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICRON GREEN 0 (3,5) 75CM HR37S(M)POW

    MDR report key: 6647234 · Received June 16, 2017

    Report

    Report Number
    3003639970-2017-00316
    Event Type
    Malfunction
    Date Received
    June 16, 2017
    Report Date
    July 7, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    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 COMPLIANT: (B)(6). IT WAS REPORTED BY THE PHYSICIAN THAT DURING ALL PROCEDURES THE SUTURES USED IS FRAYED AND IS BROKEN. THIS IS CAUSING DELAYS AND TRAUMA.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 16 PREMICRON GREEN 0 (3.5) 75CM HR37S SUTURE UNITS ARE RECEIVED IN ORIGINAL CLOSED PACKAGE. PRELIMINARY ANALYSIS: INVENTORY REVIEW: WE REVIEW THE AVAILABLE UNITS OF THIS PRODUCT CODE AND BATCH NUMBER, AND IT IS VERIFIED THAT TO DATE THERE ARE NO UNITS IN STOCK. (B)(4). BACKGROUND: THE ANALYZES PERFORMED FOR BATCH RELEASE, COMPLIED WITH THE REQUIREMENTS OF THE USP AND THE REQUIREMENTS OF B. BRAUN FOR THIS CALIBER OF THE SUTURE. RESULTS RESISTANCE TO TENSION IN THE KNOT: AVERAGE: 3.32 KGF, MAXIMUM: 3.48 KGF, MINIMUM: 3.11 KGF (USP REQUIREMENT: 2.16 KGF). ANALYSIS OF SAMPLE (S): THE SAMPLES RECEIVED WERE VISUALLY CHECKED, WERE IN THEIR ORIGINAL UNOPENED, UNOPENED PACKAGING; WERE TAKEN 5 UNITS TO PERFORM RESISTANCE TEST AT THE NODE: RESULT: AVERAGE: 3.47 KGF, MAXIMUM: 3.75 KGF, MINIMUM: 3.31 KGF (USP REQUIREMENT: 2.16 KGF). ALSO A KNOTTING TEST WAS CARRIED OUT STARTING WITH A DOUBLE AND A SEQUENCE OF UP TO 8 KNOTS WITHOUT PRESENTING FRAYING OR BREAKING IN THE THREAD. FINAL CONCLUSION: BASED ON THE ANALYSIS CARRIED OUT ON THE SAMPLES RECEIVED THE COMPLAINT WAS DETERMINED UNCONFIRMED, BECAUSE THE ANALYZES COMPLIED WITH THE USP AND B. BRAUN REQUIREMENTS FOR THIS SUTURE. ACTIONS ON THE DISTRIBUTED PRODUCT OF THIS REFERENCE / LOT: BASED ON THE CONCLUSION DERIVED FROM THE INVESTIGATION, IT IS NOT NECESSARY TO CARRY OUT ACTIONS ON THE DISTRIBUTED PRODUCT. ACTIONS: NO CORRECTIVE OR PREVENTIVE ACTION IS TAKEN IN THIS REGARD, SINCE IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF NON-COMPLIANCE. THE ANALYZES OF THE SAMPLES WERE SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428998 PREMICRON GREEN 0 (3,5) 75CM HR37S(M)POW SUTURES GAT B.BRAUN SURGICAL SA C0026747 516253

    Patients

    Seq Age Sex Outcome Treatment
    1 Other