BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILKAM BLACK 3/0 (2) 75CM HR22

    MDR report key: 8836990 · Received July 29, 2019

    Report

    Report Number
    3003639970-2019-00560
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Report Date
    August 29, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLES RECEIVED: 13 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 13 CLOSED SAMPLES FOR ANALYSIS. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 1.23 KGF IN AVERAGE AND 1.12 KGF IN MINIMUM (EP REQUIREMENTS: 0.92 KGF IN AVERAGE AND 0.31 KGF IN MINIMUM) WE HAVE CONDUCTED A REVIEW OF THE BATCH MANUFACTURING RECORD OF THIS PRODUCT AND THERE WAS AN INTERNAL NON CONFORMITY. THIS PRODUCT WAS RELEASED INTO THE MARKET FULFILLING USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. KNOT PULL TENSILE STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE 1.31 KGF IN AVERAGE AND 1.29 KGF IN MINIMUM AND FULFILLED EP REQUIREMENTS. 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

    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. WHEN ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE THREAD IS CRACKED. 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
    631369 SILKAM BLACK 3/0 (2) 75CM HR22 OTHER SUTURE GAP B.BRAUN SURGICAL SA C0760307 619061

    Patients

    Seq Age Sex Outcome Treatment
    1