BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SC UPMD SET

    MDR report key: 7591495 · Received June 12, 2018

    Report

    Report Number
    3003639970-2018-00372
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Report Date
    June 29, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    SAMPLES RECEIVED: 101 UNOPENED PRO-SETS AND 1 OPENED. ANALYSIS AND RESULTS: WE MANUFACTURED 120 PRO-SETS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED ONE OPEN PRO-SET THAT CONTAINS AN OPEN POUCH OF THE CODE-BATCH C0068663-118042 (NOVOSYN VIOLET 0 (3.5) 90CM HRN50) WITH A DIFFERENT SUTURE INSIDE. WE HAVE ALSO RECEIVED 101 CLOSED PRO-SETS (55 OF THEM CONTAIN THE CODE-BATCH C0068663-118042). WE HAVE OPENED THE 55 CLOSED POUCHES OF THE INVOLVED CODE-BATCH C0068663-118042 AND WE HAVE FOUND 9 WITH A DIFFERENT SUTURE INSIDE (THE SAME AS THE OPEN SAMPLE RECEIVED). WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THE CODE-BATCH C0068663-118042. THERE ARE NO UNITS IN OUR STOCK. THE DIFFERENT SUTURE HAS BEEN CHARACTERIZED AND HAS BEEN IDENTIFIED AS SAFIL VIOLET OF USP 1 AND 70 CM LENGTH WITH HRT40S NEEDLE (EQUIVALENT CODE C1048484). REVIEWED THE BATCH MANUFACTURING RECORDS, THE SAME OPERATOR WAS PRESENT IN THE ASSEMBLING AND WINDING STEP OF THE REFERENCE C1048484 AND BATCH 118036. AFTER INVESTIGATION, THE MOST PROBABLE ROOT CAUSE IS THAT BY OPERATOR MISTAKE AFTER WINDING STEP IN THE MANUFACTURING LINE, SOME SUTURES OF SAFIL WERE PLACED IN THE NOVOSYN ORDER AND WERE LABELED AS NOVOSYN (CODE-BATCH C0068663-118042). 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. CORRECTIVE/PREVENTIVE ACTIONS: COMPLAINT IS ADDED TO SIX_05_2012 SIX SIGMA PROJECT REGARDING MIX-UP INSIDE FIRST PACK.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: CZECH REPUBLIC. IT WAS REPORTED THAT THE WRONG PRODUCT WAS INSIDE THE FIRST PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436592 SC UPMD SET SUTURES GAT B.BRAUN SURGICAL SA 75652 P180207003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other