BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 4/0 (1.5) 90CM 2XHR17 CV

    MDR report key: 17609973 · Received August 24, 2023

    Report

    Report Number
    3003639970-2023-00275
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    August 2, 2023
    Report Date
    August 24, 2023
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 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. UNDER PMA/510(K) NUMBER: K980703. COMPLAINT DESCRIPTION: TWO PRODUCTS WERE FOUND TO HAVE NEEDLE AND THREAD SEPARATION BEFORE USE, AND TWO OTHERS FELL OFF DURING USE. PATIENT INFORMATION: NOT AVAILABLE. SAMPLES RECEIVED: NONE. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE RECEIVED A PICTURE SHOWING ONE DETACHED NEEDLE STILL IN THE PACK AND A THREAD DETACHED BUT NO NEEDLE IN THE PACK. NEVERTHELESS, WITHOUT CLOSED AND/OR DEFECTIVE SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. 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: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. 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 PREMILENE SUTURE. THE CLIENT REPORTED THAT TWO PRODUCTS WERE FOUND TO HAVE NEEDLE AND THREAD SEPARATION BEFORE USE, AND TWO OTHER FELL OFF DURING USE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52441 PREMILENE 4/0 (1.5) 90CM 2XHR17 CV CARDIAC SUTURE GAW B. BRAUN SURGICAL, S.A. C2090902 120246

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown