BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICRON GRN 2/0 (3) 90CM 2XHRT26(M)RCP

    MDR report key: 8709452 · Received June 18, 2019

    Report

    Report Number
    3003639970-2019-00481
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    May 20, 2019
    Report Date
    July 22, 2019
    Manufacturer
    B. BRAUN SURGICAL SA
    Product Code
    GAT
    PMA / PMN Number
    K012201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    G1-2: CONTACT INFORMATION UPDATED DUE TO THE EXPIRATION OF EXEMPTION E2014012. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: (B)(4) UNOPENED RACE PACKS AND (B)(4) OPENED. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED (B)(4) CLOSED SAMPLES AND 2 OPENED WITH THE NEEDLE DETACHED FROM THE THREAD. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS DO NOT FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP). WE REVIEWED THE BATCH MANUFACTURING RECORD. THERE ARE NO INCIDENCES RELATED TO THIS ISSUE AND THE RESULTS DURING THE PROCESS FULFILLED USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLES RECEIVED DO NOT FULFIL THE SPECIFICATIONS OF THE EUROPEAN PHARMACOPOEIA/B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED. 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 · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: INVESTIGATION IS ON-GOING. ADDITIONAL INFORMATION/INVESTIGATIONAL RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE NEEDLE "FALLS OUT FROM THE THREAD" AS THE PRODUCT IS REMOVED FROM THE PACKAGE. NO ASSOCIATED INJURIES OR COMPLICATIONS ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500166 PREMICRON GRN 2/0 (3) 90CM 2XHRT26(M)RCP SUTURES GAT B. BRAUN SURGICAL SA C2026446 118312

    Patients

    Seq Age Sex Outcome Treatment
    1