BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOCRIN 4/0 (1.5) 75CM DS16

    MDR report key: 4213789 · Received August 14, 2014

    Report

    Report Number
    2916714-2014-00660
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Report Date
    August 14, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON: (B)(4) 2014. THE REPORTED DEVICE IS NOT MARKETED IN THE US., HOWEVER, SIMILAR PRODUCTS, PROCESSES, AND COMPONENTS ARE. MANUFACTURING SITE EVALUATION. SAMPLES RECEIVED: (B)(4) UNOPENED UNITS ((B)(4) BOXES), ALL WITH THE SAME DEFECT. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. THERE ARE (B)(4) UNITS OF FLEXOCRIN 0862223 BATCH (B)(4) WERE MANUFACTURED, THERE ARE (B)(4) UNITS IN STOCK THAT HAVE BEEN REVIEWED AND ARE CORRECT. ALL BOXES (B)(4) ARE FLEXOCRIN PRE-PRINTED BOX LABELED AS FLEXOCRIN 4/0 75CM DS16 (G0862223; BATCH (B)(4)) BUT ALL THE UNITS INSIDE THE BOXES ARE SILKAM 1 75CM GS60 (G0864690; BATCH (B)(4)). THE MISTAKE TOOK PLACE IN THE WAREHOUSE WHEN PREPARING THE SHIPMENT. BOTH PRODUCTS WERE LABELED MANUALLY, AND THE PERSON IN CHARGE OF CHECKING THE PRODUCT PREVIOUS TO THE SHIPMENT DID NOT NOTICE THIS MISTAKE. FINAL CONCLUSION: THE COMPLAINT IS CORRESPONDING (JUSTIFIED). CORRECTIVE/PREVENTIVE ACTIONS: CAPA HAS BEEN OPENED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). COMPLAINT STATES: THE CUSTOMER HAS FOUND THE SILKAM IN A BOX OF THE FLEXOCRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487943 FLEXOCRIN 4/0 (1.5) 75CM DS16 NYLON SUTURE GAW B. BRAUN SURGICAL S.A. G0862223 614096

    Patients

    Seq Age Sex Outcome Treatment
    1