BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 5/0 (1) 75CM 2XDR13 CV

    MDR report key: 3850439 · Received March 18, 2014

    Report

    Report Number
    2916714-2014-00166
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    February 7, 2014
    Report Date
    March 18, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAW
    PMA / PMN Number
    K980703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MFG SITE EVAL: SAMPLES RECEIVED: 2 UNOPENED RACEPACKS. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OUR STOCK. TESTED THE NEEDLE ATTACHMENT OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE OEM. REVIEW THE BATCH MFG RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. REMARKS: THE COMPLAINT IS JUSTIFIED FOR ISOLATED DETACHED NEEDLES, BUT THE CONCLUSION IS NOT CORRESPONDING ACCORDING TO THE RESULTS OF THE SAMPLES TESTED. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTIONS ON PRODUCT: NOT APPLICABLE. CORRECTIVE/ PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THREAD DETACHED FROM NEEDLE VERY EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160556 PREMILENE 5/0 (1) 75CM 2XDR13 CV NON-ABSORBABLE SUTURE GAW B. BRAUN SURGICAL S.A. C2095907 113282V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other