BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAFILON BLACK 10/0 (0.2) 30CM 2XDLM6

    MDR report key: 7873474 · Received September 13, 2018

    Report

    Report Number
    3003639970-2018-00559
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Report Date
    October 5, 2018
    Manufacturer
    B BRAUN SURGICAL SA
    Product Code
    GAR
    PMA / PMN Number
    K990090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. A REVIEW OF THE BATCH RECORDS UTILIZING BATCH NUMBER 117482 REVEALED NO SIMILAR INCIDENCES FOR THIS EVENT. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, NO INVESTIGATIONAL RESULTS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE PACKAGE WAS OPENED, THE NEEDLE AND THE SUTURE WERE FOUND TO BE SEPARATED. AT THE TIME OF THE EVENT, THE NEEDLE AND SUTURE WERE NOT IN USE ON A PATIENT.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 1 OPEN POUCH (AND 1 UNOPENED POUCH FROM ANOTHER BATCH THAT WILL NOT BE ANALYZED). ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED (B)(4) UNITS IN THE MARKET. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED AN OPEN SAMPLE (SEEMS UNUSED) WITH ONE OF THE NEEDLES DETACHED FROM THE THREAD. THE OTHER NEEDLE (DOUBLE ARMED PRODUCT) IS CONNECTED TO THE THREAD. NEVERTHELESS, NEEDLE ATTACHMENT STRENGTH TEST TO THE ATTACHED NEEDLE CANNOT BE DONE BECAUSE THE THREAD IS BROKEN APPROXIMATELY 1CM FROM THE NEEDLE AND THE TEST CANNOT BE CARRIED OUT. TAKING INTO ACCOUNT THAT NO OTHER CUSTOMER COMPLAINTS HAVE BEEN RECEIVED CONCERNING THIS ISSUE FOR THIS CODE-BATCH WE CONSIDER THAT THIS IS AN ISOLATED UNIT. 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: IN SPITE OF RECEIVING A DEFECTIVE SAMPLE, WITHOUT CLOSED SAMPLES A SUITABLE ANALYSIS CANNOT BE PERFORMED. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY CLOSED SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713249 DAFILON BLACK 10/0 (0.2) 30CM 2XDLM6 DAFILON GAR B BRAUN SURGICAL SA G1118706 117482

    Patients

    Seq Age Sex Outcome Treatment
    1