BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 4/0 (1.5) 75CM HR26 (M) CV

    MDR report key: 9214338 · Received October 21, 2019

    Report

    Report Number
    3003639970-2019-00721
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    October 3, 2019
    Report Date
    October 21, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. K980703. INVESTIGATION: SAMPLES RECEIVED: 30 UNOPENED RACEPACKS. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE (B)(4) UNITS IN STOCK BLOCKED. WE HAVE RECEIVED 30 CLOSED SAMPLES FROM THE CUSTOMER FOR ANALYSIS. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 1.01 KGF IN AVERAGE AND 0.71 KGF IN MINIMUM (EP REQUIREMENTS: 0.46 KGF IN AVERAGE AND 0.23 KGF IN MINIMUM) HOWEVER, WE HAVE FOUND THREAD SPLITTING NEAR THE NEEDLE ATTACHMENT AREA IN 4 OF THE 30 SAMPLES TESTED DURING PERFORMING NEEDLE ATTACHMENT STRENGTH TEST. A FAULTY NEEDLE ATTACHMENT PROCESS (TOO MUCH STRENGTH APPLIED) COULD CAUSE THIS SPLITTING. 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: TAKING INTO ACCOUNT THAT 4 OF THE 30 SAMPLES RECEIVED DO NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE FAILURE IS SOME 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/PREVENTATIVE ACTIONS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NEEDLE DETACHED. THE REPORTER INDICATED THAT WHEN THE PACKET WAS OPENED THE NEEDLE SEPARATED FROM THE THREAD. NO PATIENT INFORMATION IS AVAILABLE AS THIS EVENT OCCURRED BEFORE USE IN A VETERINARY CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009960 PREMILENE 4/0 (1.5) 75CM HR26 (M) CV OTHER SUTURE GAW B.BRAUN SURGICAL SA C2090040 117485

    Patients

    Seq Age Sex Outcome Treatment
    1