BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILKAM BLACK 0 (3.5) 75CM HS30

    MDR report key: 9558587 · Received January 7, 2020

    Report

    Report Number
    3003639970-2019-00960
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    December 17, 2019
    Report Date
    March 2, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLES RECEIVED: 30 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 30 CLOSED SAMPLES FOR ANALYSIS. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF ALL SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 2.60 KGF IN AVERAGE AND 2.45 KGF IN MINIMUM (EP REQUIREMENTS: 2.24 KGF IN AVERAGE AND 1.33 KGF IN MINIMUM). REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. REMARKS: WHEN WORKING WITH SILKAM GREAT CARE MUST BE TAKEN TO ENSURE THAT THE USE OF SURGICAL INSTRUMENTS, SUCH AS TWEEZERS OR NEEDLE HOLDER, DOES NOT LEAD TO CRIMPING DAMAGE OF THE SUTURE. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. 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 · 1

    PMA/510K: 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. K990089. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADS BREAK. THE REPORTER INDICATED THAT THE THREAD BROKE DURING SURGERY. PATIENT INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20518 SILKAM BLACK 0 (3.5) 75CM HS30 OTHER SUTURE GAP B.BRAUN SURGICAL SA C0764620 619224

    Patients

    Seq Age Sex Outcome Treatment
    1