BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILKAM BLACK 2/0 (3) 17X45CM

    MDR report key: 14235580 · Received April 28, 2022

    Report

    Report Number
    3003639970-2022-00182
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 1, 2022
    Report Date
    June 27, 2022
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAP
    PMA / PMN Number
    K990089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED (B)(4) UNITS OF THIS CODE BATCH. THERE WERE (B)(4) UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE, (B)(4) UNITS HAVE BEEN REQUESTED FOR ANALYSIS. WE HAVE RECEIVED (B(B)(4) OPEN AND EMPTY SAMPLES. NO ANALYSIS CAN BE DONE TO THESE SAMPLES. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED FROM STOCK AND THE RESULTS FULFILL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 2.20 KGF IN AVERAGE AND 2.02 KGF IN MINIMUM (EP REQUIREMENTS: 1.53 KGF IN AVERAGE AND 0.92 KGF IN MINIMUM). REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FROM STOCK 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. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH SILKAM SUTURE. THE CLIENT REPORTED THAT THE SUTURE BROKE EASILY WHEN THE DOCTOR TIED IT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195912 SILKAM BLACK 2/0 (3) 17X45CM SILK SUTURE GAP B. BRAUN SURGICAL, S.A. C0266868 621021

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown