BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 3/0 (2) 75CM DS24 (M)

    MDR report key: 9453743 · Received December 11, 2019

    Report

    Report Number
    3003639970-2019-00872
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Report Date
    December 11, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. K111375. INVESTIGATION: ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED 5,724 UNITS IN THE MARKET. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED THREE CLOSED SAMPLES AND TWO OPEN AND UNUSED SAMPLES FOR ANALYSIS. THE NEEDLE IN THE TWO OPEN SAMPLES RECEIVED IS DETACHED FROM THE THREAD AND THE THREAD IS STILL WOUND ON THE PACK. TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP):1.06 KGF IN AVERAGE AND 0.78 KGF IN MINIMUM (EP REQUIREMENTS: 0.23 KGF IN AVERAGE AND 0.11 KGF IN MINIMUM). TAKING INTO ACCOUNT THAT THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH AND THE CLOSED SAMPLES RECEIVED FULFIL THE EP REQUIREMENTS, WE CONSIDER THAT ARE ISOLATED UNITS, BUT THE WHOLE BATCH IS CORRECT. 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: IN SPITE OF RECEIVING TWO DEFECTIVE SAMPLES, THE RESULTS OF THE CLOSED SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY CLOSED SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT. 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 THREAD RIPPED. THE REPORTER INDICATED THAT THE THREAD BROKE DURING SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED. PATIENT INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243617 PREMILENE 3/0 (2) 75CM DS24 (M) OTHER SUTURE GAW B.BRAUN SURGICAL SA C2090235 117212V004

    Patients

    Seq Age Sex Outcome Treatment
    1