BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 0(3,5)8X45CM HR40S TO(M)

    MDR report key: 8866739 · Received August 6, 2019

    Report

    Report Number
    3003639970-2019-00590
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    July 22, 2019
    Report Date
    September 9, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING EVALUATION: ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 4 CLOSED SAMPLES FOR ANALYSIS. NEEDLE ATTACHMENT STRENGTH TEST HAS BEEN CONDUCTED ON ALL SUTURES OF 4 CLOSED SAMPLES RECEIVED TO ANALYZE IF THEY FULFIL THE B. BRAUN REQUIREMENTS (MINIMUM VALUE 0.080 KGF, MAXIMUM VALUE 1.700 KGF). THE RESULTS FOR MAXIMUM DO NOT FULFIL B. BRAUN REQUIREMENT (VALUES OBTAINED ARE: 2.609 KGF, 2.346 KGF, 2.318 KGF, 2.581 KGF, 2.240 KGF). ON THE CONTRARY, RESULTS FOR MINIMUM WERE 0.176 KGF AND FULFIL B. BRAUN REQUIREMENTS. HOWEVER, ALL VALUES ABOVE THE MAXIMUM LIMIT CORRESPOND TO SUTURES FROM ONE OF THE SAMPLES ANALYZED. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSIONS: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLES RECEIVED DO NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS FOR NEEDLE DETACHMENT TOO HARD, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. IN CONTRAST, WE CONSIDER THIS COMPLAINT AS NOT CONFIRMED FOR NEEDLE DETACHMENT EASILY.

    Additional Manufacturer Narrative · 1

    REPORTER ADDRESS WILL BE UPDATED, WHEN INFORMATION IS PROVIDED. 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. K031286. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE SAFIL SUTURE. DURING AN UNSPECIFIED SURGERY, THE SUTURE AND NEEDLE DETACHED EASILY. THE SURGEON STATED THAT THE MATERIAL WAS HARD AND UNEVEN WITHIN ONE PACKET. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657353 SAFIL VIOLET 0(3,5)8X45CM HR40S TO(M) SYNTHETIC ABSORBABLE BRAIDED GAM B.BRAUN SURGICAL SA M1078116

    Patients

    Seq Age Sex Outcome Treatment
    1