BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOCRIN 5/0 (1) 60CM DS16

    MDR report key: 3970154 · Received April 29, 2014

    Report

    Report Number
    2916714-2014-00316
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 29, 2014
    Manufacturer
    B BRAUN SURGICAL S.A.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    "REPORTED DEVICE NOT MARKETED IN THE US, HOWEVER, SIMILAR DEVICE IS." MANUFACTURING SITE EVAL: SAMPLES RECEIVED: 1 OPEN UNIT. THERE ARE PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OEM STOCK. WE HAVE RECEIVED 1 OPEN SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD. THREAD IS STILL WOUND ON THE PACK. TESTED THE NEEDLE ATTACHMENT OF THE SAMPLES RECEIVED AND THE RESULTS DO NOT FULFIL THE REQUIREMENTS OF THE OEM. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS CORRESPONDING (JUSTIFIED). CORRECTIVE/PREVENTIVE ACTIONS: OEM HAS OPENED A CORRECTIVE ACTION IN ORDER TO AVOID THIS KIND OF INCIDENTS IN THE FUTURE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). NEEDLE DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255602 FLEXOCRIN 5/0 (1) 60CM DS16 NYLON SUTURE GAM B BRAUN SURGICAL S.A. C0862274 1-9511

    Patients

    Seq Age Sex Outcome Treatment
    1