BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 4/0 (1.5) 75CM HR17 CV

    MDR report key: 3880734 · Received May 28, 2014

    Report

    Report Number
    2916714-2014-00408
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    March 26, 2014
    Report Date
    May 28, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAW
    PMA / PMN Number
    K122734
    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)(6) 2014. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 1 BOX WITH 36 UNITS. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH THERE WERE (B)(4) UNITS MANUFACTURED AND DISTRIBUTED. THE BOX RECEIVED IS LABELED AS C2090013 (PREMILENE 4/0 75CM HR17) WITH BATCH NUMBER (B)(4). BUT INSIDE THE BOX THERE IS THE REFERENCE C2090949 (PREMILENE 3/0 90CM 2XDRT26) WITH BATCH NUMBER (B)(4). THIS MIX-UP HAS BEEN PRODUCED IN THE MANUFACTURING LINE AT THE MOMENT OF PACKAGING THE PRODUCT. BOTH ARTICLES WERE PACED IN THE SAME LINE AND SAME DAY, ONE AFTER THE OTHER. LINE CLEARANCE WAS NOT PERFORMED CORRECTLY. FINAL CONCLUSION: THE COMPLAINT IS CORRESPONDING (JUSTIFIED). CORRECTIVE ACTION: OEM HAS INITIATED CORRECTIVE ACTION TO AVOID THIS INCIDENT IN THE FUTURE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). WRONG PRODUCT IN THE BOX. LABEL OF THE BOX IS C2090013, AND THE PRODUCT IN THE BOX IS C2090949.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313869 PREMILENE 4/0 (1.5) 75CM HR17 CV CARDIAC SUTURE GAW B. BRAUN SURGICAL S.A. C2090013 110223V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other