BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6110295 · Received November 17, 2016

    Report

    Report Number
    2916714-2016-00963
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 7, 2016
    Report Date
    February 9, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    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. (B)(4) (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: COLOMBIA. IT WAS REPORTED THAT THE THREAD IS SPLITTING DURING SURGERY.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 3 UNITS OF PREMILENE 2/0 (3) 75CM DS24 UNUSED, IN ORIGINAL, CLOSED PACKAGE. PRELIMINARY ANALYSIS: STOCK REVIEW: AFTER REVIEWING THE STOCK, IT WAS VERIFIED THAT UNITS OF THIS PRODUCT CODE AND LOT NUMBER ARE NOT CURRENTLY AVAILABLE. QUANTITY PRODUCED / IMPORTED: THE TRACEABILITY IS CHECKED AND VERIFIED THAT OF THIS LOT AND PRODUCT CODE, A TOTAL OF (B)(4) UNITS WERE MADE. DISTRIBUTED QUANTITY: THE ENTIRE LOT WAS DISTRIBUTED IN 27 CLIENTS, WHICH ARE LOCATED IN CITIES SUCH (B)(4). BACKGROUND: REVIEWED THE DATABASE OF CLAIMS AND VERIFIED THAT TO DATE, THER ARE NO INCIDENT REPORTS THAT ARE RELATED TO THIS PRODUCT CODE AND LOT NUMBER. BATCH RECORD / BATCH RECORD: THE DOCUMENTATION FOR THE BATCH MANUFACTURING WAS REVIEWED AND THERE IS NO RECORD OF DEVIATIONS OR ALTERATIONS DURING THE PROCESS. RESULTS FOR BATCH RELEASE: IN RELATION TO THE RESULTS OBTAINED FOR THE RELEASE OF THE BATCH, WITH RESPECT TO THE RESISTANCE TO TENSION IN THE KNOT, THE BATCH COMPLIED WITH THE REQUIREMENTS REQUIRED FOR THIS TYPE OF SUTURE; DID NOT SHOW DE-LAMINATION. ANALYSIS OF SAMPLE (S): VISUAL CHECK WAS PERFORMED ON SAMPLES RECEIVED AND UNITS WERE SEALED. A KNOT STRENGTH TEST WAS PERFORMED ON THE YARN, WITH THE SAMPLES RECEIVED AND THE DE-LAMINATION NOT EVIDENT. THE VISUAL ASPECT IS THE USUAL ONE, AS IT CAN BE SEEN IN THE ATTACHED IMAGE. WITH RESPECT TO THIS CAUSE, THE DE-LAMINATION OF THE THREAD IS NOT A BEHAVIOR THAT IS EVIDENT IN THE RAW MATERIAL. CONCLUSIONS: COMPLAINT IS JUSTIFIED. TAKING INTO ACCOUNT THAT THE SUTURE USED BY THE CLIENT DID NOT FULFILL THE OEM SPECIFICATIONS. ACTIONS: PREVENTIVE / CORRECTIVE ACTIONS, IT WILL PROCEED TO INFORM THE SUPPLIER OF THE RAW MATERIAL ABOUT THE INCIDENT PRESENTED IN ORDER TO EVALUATE ITS PROCESSES, THUS MINIMIZING THE RISK AND PREVENT THIS FAILURE FROM RECURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760316 PREMILENE 2/0 (3) 75CM DS24 (M) POW SUTURES GAW B.BRAUN SURGICAL SA C0095731 516015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other