BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 0 (3.5) 70CM HR37S (M)

    MDR report key: 8552137 · Received April 25, 2019

    Report

    Report Number
    3003639970-2019-00392
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Report Date
    June 14, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    K031286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    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 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. WHEN ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(6) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. INVESTIGATION: SAMPLES RECEIVED: 29 UNOPENED POUCHES AND 2 OPENED. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 5,292 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 29 CLOSED SAMPLES AND 2 OPEN AND UNUSED SAMPLES. WE HAVE CHECKED ALL SAMPLES RECEIVED AND WE HAVE FOUND THAT 18 OF THE CLOSED SAMPLES RECEIVED HAVE THE CORRECT PRODUCT INSIDE (SAFIL VIOLET 0 (3.5) 70CM HR37S). HOWEVER, THE OTHER 11 CLOSED SAMPLES AND THE 2 OPEN SAMPLES CONTAIN A DIFFERENT SUTURE INSIDE. THE DIFFERENT SUTURE HAS BEEN CHARACTERIZED AND HAS BEEN IDENTIFIED AS SAFIL VIOLET OF USP 2/0 AND 70 CM LENGTH WITH HR26 NEEDLE (EQUIVALENT CODE C1048042). REVIEWED THE BATCH MANUFACTURING RECORDS, THE MOST LIKELY ROOT-CAUSE IS DUE TO THE OPERATION OF LINE CLEARANCE WAS NOT PERFORMED CORRECTLY IN THE NEEDLE ATTACHMENT PROCESS. PROBABLY, SOME SUTURES OF THE PREVIOUS ORDER THAT CORRESPONDS TO SAFIL VIOLET 2/0 70CM WITH HR26 NEEDLE WERE WOUND AND PACKED AS SAFIL VIOLET 0 70 HR37S. 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 DISTRIBUTED PRODUCT OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. YOU WILL RECEIVE A CREDIT NOTE FOR ONE BOX AS COMPENSATION. CORRECTIVE/PREVENTIVE ACTIONS: COMPLAINT IS ADDED TO SIX SIGMA PROJECT REGARDING MIX-UP INSIDE FIRST PACK.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NEEDLE SIZE IS SMALLER THAN IT SHOULD BE. THE REPORTER INDICATED THAT THE NEEDLE SIZE DOES NOT MATCH THE SIZE OF THE RESPECTIVE ARTICLE. THE SIZE IS LESS THAN IT SHOULD BE. THIS WAS NOTICED BEFORE USE. NO OTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346052 SAFIL VIOLET 0 (3.5) 70CM HR37S (M) SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA C1048096 118404

    Patients

    Seq Age Sex Outcome Treatment
    1