BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAFILON BLUE 3/0 (2) 75CM DGMP24 DDP

    MDR report key: 20426866 · Received October 11, 2024

    Report

    Report Number
    3003639970-2024-00366
    Event Type
    Malfunction
    Date Received
    October 11, 2024
    Date of Event
    September 11, 2024
    Report Date
    October 11, 2024
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAR
    PMA / PMN Number
    K151165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY OF INVESTIGATION: 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 OUR STOCK. WE HAVE RECEIVED 9 CLOSED SAMPLES FOR ANALYSIS. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA: 1.19 KGF IN AVERAGE AND 0.95 KGF IN MINIMUM (EP REQUIREMENTS: 0.69 KGF IN AVERAGE AND 0.35 KGF IN MINIMUM). BATCH MANUFACTURING RECORD: REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED USP/EUROPEAN PHARMACOPOEIA AND B. BRAUN SURGICAL REQUIREMENTS. CONCLUSION ROOT CAUSE ANALYSIS: IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE BECAUSE THE CLOSED SAMPLES RECEIVED COMPLY USP/EP AND B. BRAUN SURGICAL REQUIREMENTS REGARDING NEEDLE ATTACHMENT STRENGTH. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE CLOSED SAMPLES RECEIVED FULFIL 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 CLOSED SAMPLES RECEIVED. CORRECTIVE MEASURES: 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 DAFILON SUTURE. THE CLIENT REPORTED THAT THE NEEDLE CAME LOOSE FROM THREAD AND BROKE VERY QUICKLY. ACCORDING TO PHW, WITH ALMOST EVERY THREAD. DURING SURGERY. FURTHER INFORMATION HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301206 DAFILON BLUE 3/0 (2) 75CM DGMP24 DDP OTHER SUTURES GAR B. BRAUN SURGICAL, S.A. C0934005 624262

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose