BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVIX SET WHT TAPE 0.5CM 50CM 2XHRN45

    MDR report key: 8349983 · Received February 19, 2019

    Report

    Report Number
    3003639970-2019-00168
    Event Type
    Malfunction
    Date Received
    February 19, 2019
    Date of Event
    January 18, 2019
    Report Date
    May 16, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAT
    PMA / PMN Number
    K990088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLES RECEIVED: 3 CLOSED SAMPLES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. WE MANUFACTURED (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE 24 UNITS IN OUR STOCK. WE HAVE RECEIVED THREE CLOSED SAMPLES TO ANALYZE THIS CASE. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE B. BRAUN SURGICAL REQUIREMENT: 136.03 N IN AVERAGE AND 123.20 N IN MINIMUM (BBS REQUIREMENT: > 90 N). ADDITIONALLY, WE HAVE ALSO TESTED NEEDLE ATTACHMENT STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE B. BRAUN SURGICAL REQUIREMENTS: 108 N IN AVERAGE AND 55.6 KGF IN MINIMUM (BBS REQUIREMENTS: 15 N IN AVERAGE AND 7 N IN MINIMUM). THE BATCH MANUFACTURING RECORD OF THIS PRODUCT HAS BEEN REVIEWED AND NO DEVIATIONS HAVE BEEN FOUND. ACCORDING TO THE RESULTS OF THE SAMPLES TESTED AND THE BATCH MANUFACTURING RECORD REVIEW, THE PRODUCT COMPLIES WITH OUR SPECIFICATIONS. THEREFORE, WE DO NOT SEE ANY MANUFACTURING FAULT OR MATERIAL DEFECT THAT COULD HAVE CAUSED THE INCIDENCE. 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. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    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 ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE CERVIX SET WHITE TAPE. DURING USE, IT WAS NOTED THAT THE SUTURE RIPPED WHILE BEING APPLIED TO THE CERVIX. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143478 CERVIX SET WHT TAPE 0.5CM 50CM 2XHRN45 OTHER SUTURE GAT B.BRAUN SURGICAL SA 997145 218334

    Patients

    Seq Age Sex Outcome Treatment
    1