BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAFILON BLUE 5/0 (1) 45CM DS16

    MDR report key: 9682355 · Received February 7, 2020

    Report

    Report Number
    3003639970-2020-00081
    Event Type
    Malfunction
    Date Received
    February 7, 2020
    Date of Event
    January 1, 2020
    Report Date
    March 23, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAR
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLES RECEIVED: THERE ARE NO SAMPLES AVAILABLE FOR ANALYSIS. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND MOSTLY DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE WERE (B)(4) UNITS IN STOCK THAT WERE REQUESTED FOR ANALYSIS. WITHOUT ANY SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. NEVERTHELESS, WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE SAMPLES RECEIVED FROM STOCK AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.69 KGF IN AVERAGE AND 0.38 KGF IN MINIMUM (EP REQUIREMENTS:0.23 KGF IN AVERAGE AND 0.11 KGF IN MINIMUM) REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL 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. 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

    K990090. 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. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT, IF APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH DAFILON BLUE SUTURE. THE CUSTOMER REPORTED THAT THE THREAD DETACHED FROM THE NEEDLE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144940 DAFILON BLUE 5/0 (1) 45CM DS16 OTHER SUTURE GAR B.BRAUN SURGICAL SA C0932124 619152

    Patients

    Seq Age Sex Outcome Treatment
    1