BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAFILON BLUE 2/0 (3) 75CM DS30

    MDR report key: 9158617 · Received October 4, 2019

    Report

    Report Number
    3003639970-2019-00674
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    September 9, 2019
    Report Date
    October 4, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAR
    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 · 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 UNOPENED POUCH. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 12,744 UNITS. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED ONE CLOSED SAMPLE. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE CLOSED SAMPLE RECEIVED AND THE RESULT FULFILL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 1.90 KGF (EP REQUIREMENTS: 1.12 KGF IN AVERAGE AND 0.46 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. NEEDLE ATTACHMENT RESULTS BEFORE RELEASING THE PRODUCT WERE 2.20 KGF IN AVERAGE AND 1.56 KGF IN MINIMUM AND FULFILLED EP REQUIREMENTS. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLE 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 · 1

    IT WAS REPORTED THAT THE NEEDLE DETACHMENT. THE REPORTER INDICATED THAT THE NEEDLE DETACHED FROM THE THREAD ON SEVERAL UNITS. EVENT OCCURRED AT A VETERINARY CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950554 DAFILON BLUE 2/0 (3) 75CM DS30 OTHER SUTURE GAR B.BRAUN SURGICAL SA C0935476 616391

    Patients

    Seq Age Sex Outcome Treatment
    1