BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8984107 · Received September 10, 2019

    Report

    Report Number
    3003639970-2019-00627
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    August 15, 2019
    Report Date
    September 20, 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 IS ONE PREVIOUS COMPLAINT OF THIS CODE-BATCH REGARDING THE SAME ISSUES AND CLOSED AS CONFIRMED AFTER ANALYSIS. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED FOUR CLOSED SAMPLES FOR ANALYSIS. TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS ARE: 0.073 KGF IN MINIMUM AND 0.702 KGF IN MAXIMUM (BBS REQUIREMENTS: 0.080 KGF IN MINIMUM AND 1.700 KGF IN MAXIMUM). ONE OF THE RESULTS DOES NOT FULFILL BBS REQUIREMENT FOR MINIMUM. HOWEVER, 1 LOW VALUE IN 15 TESTED UNITS IS ACCEPTED, ACCORDING TO THE BBS REQUIREMENTS. NEVERTHELESS, TAKING INTO ACCOUNT THIS VALUE AND THAT THERE IS ONE PREVIOUS COMPLAINT WHERE THE RESULTS DID NOT FULFIL THE BBS REQUIREMENT, WE CONSIDER THAT THE COMPLAINT IS CONFIRMED. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSIONS: WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED.

    Additional Manufacturer Narrative · 1

    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 VIOLET SUTURE. IT WAS REPORTED THAT DURING A 30-DAY PERIOD, THE SUTURE MALFUNCTIONED. WHILE USING THE SUTURE TO CLOSE THE ABDOMEN, THE NEEDLE DETACHED WITH DIFFICULTY. ALSO, THERE WERE SOME PACKETS IN WHICH IT WAS NOTED THAT THE NEEDLE HAD ALREADY DETACHED. ADDITIONAL INFORMATION WAS NOT PROVIDED. ASSOCIATED COMPLAINTS REPORTED SEPARATELY (NO EVIDENCE THAT IT OCCURRED DURING SAME PROCEDURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775681 SAFIL VIOLET 0(3,5)8X45CM HR40S TO(M) SYNTHETIC ABSORBABLE BRAIDED GAM B.BRAUN SURGICAL SA M1078116 118412

    Patients

    Seq Age Sex Outcome Treatment
    1