BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAFILON BLUE 5/0 (1) 75CM DS19 (M)

    MDR report key: 9539027 · Received January 2, 2020

    Report

    Report Number
    3003639970-2019-00949
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Report Date
    January 2, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAR
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. K990090. INVESTIGATION: SAMPLES RECEIVED: 1 OPEN POUCH WITHOUT THE SECOND PACK. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED (B)(4) IN THE MARKET. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED A SAMPLE WITHOUT THE SECOND PACK. ONLY THE 1ST PACK IS AVAILABLE AND IT IS CLOSED. HOWEVER, WITHOUT CLOSED SAMPLES AND/OR DEFECTIVE SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. AS NO SAMPLES HAVE BEEN RECEIVED AND NO UNITS ARE AVAILABLE IN B. BRAUN SURGICAL, S.A. WE HAVE ONLY REVIEWED THE BATCH MANUFACTURING RECORD 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 ANALYZE 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. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACK STICKS. THE REPORTER INDICATED THAT THE PRODUCTS STICK/ARE SEALED ON THE OVERPOUCH PACK. THE EVENT OCCURRED PRIOR TO USE WITH NO PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060 DAFILON BLUE 5/0 (1) 75CM DS19 (M) OTHER SUTURE GAR B.BRAUN SURGICAL SA C0933236 619255

    Patients

    Seq Age Sex Outcome Treatment
    1