BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILKAM BLACK 1 (4) 75CM DS30

    MDR report key: 9190912 · Received October 15, 2019

    Report

    Report Number
    3003639970-2019-00700
    Event Type
    Injury
    Date Received
    October 15, 2019
    Date of Event
    September 24, 2019
    Report Date
    November 15, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLES RECEIVED: 79 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND MAINLY DISTRIBUTED 6,480 UNITS IN THE MARKET. THERE ARE 48 UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFILL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 3.62 KGF IN AVERAGE AND 3.34 KGF IN MINIMUM (EP REQUIREMENTS: 2.75 KGF IN AVERAGE AND 1.53 KGF IN MINIMUM). REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD AN INCIDENCE, NOT RELATED TO THIS ISSUE. THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. KNOT PULL TENSILE STRENGTH RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT WERE: 3.78 KGF IN AVERAGE AND 3.68 KGF IN MINIMUM. 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. THE CASE IS CONSIDERED NOT CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. 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.

    Description of Event or Problem · 0

    CLARIFICATION OF EVENT DETAILS: SURGERY: VASCULAR SURGERY, TISSUE SUTURED: INTRAMUSCULAR.

    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. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE THREAD BROKE. THE REPORTER INDICATED THAT DURING A VASULAR SURGICAL PROCEDURE, THE SUTURE BROKE THREE TIMES WHILE SUTURING THE INTRAMUSULAR TISSUE. THE SURGEON WAS USING AN INTERRUPTED TECHNIQUE. THERE WAS NO PATIENT INJURY OR HARM. PATIENT INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987885 SILKAM BLACK 1 (4) 75CM DS30 OTHER SUTURE GAP B.BRAUN SURGICAL SA C0762490 619085

    Patients

    Seq Age Sex Outcome Treatment
    1