BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICRON GREEN 2/0 (3) 75CM HR26 (M)

    MDR report key: 9531558 · Received December 30, 2019

    Report

    Report Number
    3003639970-2019-00941
    Event Type
    Malfunction
    Date Received
    December 30, 2019
    Date of Event
    December 2, 2019
    Report Date
    January 21, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE RECEIVED (B)(4) CLOSED AND AN OPEN UNUSED SAMPLE. THE OPEN SAMPLE RECEIVED IS CORRECT AND DOES NOT SHOW ANY DEFECT. SEWING TEST ON ARTIFICIAL SKIN TISSUE HAS BEEN CONDUCTED WITH SOME OF THE CLOSED SAMPLES RECEIVED AND FRAYING DOES NOT APPEAR WHEN PULLING THE THREAD THROUGH THE TISSUE. VISUAL APPEARANCE OF THE THREAD IS THE USUAL ONE. ADDITIONALLY, WE HAVE PERFORMED KNOTTING TEST IN SOME OF THE SAMPLES RECEIVED. IN THIS TEST, THREE KNOTS ARE DONE AND THE BEHAVIOR OF THE THREAD IS ANALYZED WHEN THE KNOT IS PULLED DOWN. IN ANY OF THE SAMPLES TESTED FRAYING HAS APPEARED AFTER PULLING DOWN THE THREE KNOTS. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. THE CASE IS CONSIDERED NOT CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Additional Manufacturer Narrative · 1

    PMA/510K: REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K012201. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREAD IS DAMAGED (FRAYING). THE REPORTER INDICATED THAT DURING A SURGICAL PROCEDURE, THE SUTURE WAS USED TO FIX A PROMONTOFIXATION PROSTHESIS. THE THREAD (WIRE) FRAYS DURING USE. PER THE REPORTER, THE SURGEON NEEDED TO CHANGE THE THREAD AT EACH POINT. FOUR PACKAGES (UNITS) FROM THE SAME BATCH NUMBER WERE USED AND THE SAME PROBLEM WAS ENCOUNTERED. THERE WAS NO DELAY IN SURGERY OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327130 PREMICRON GREEN 2/0 (3) 75CM HR26 (M) CARDIAC SUTURE GAT B.BRAUN SURGICAL SA C0026016 619232

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR