BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOCRIN (2.5) 90CM DS19

    MDR report key: 3810510 · Received April 16, 2014

    Report

    Report Number
    2916714-2014-00256
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 12, 2014
    Report Date
    April 16, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. REPORTED DEVICE NOT MARKETED IN THE US; HOWEVER, DEVICES THAT SHARE COMMON PROCESSES ARE. MFR SITE EVAL: SAMPLES RECEIVED: 7 UNOPENED UNITS. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OEM STOCK. TESTED THE NEEDLE ATTACHMENT OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE OEM. REVIEWED THE BATCH MFG RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTIONS ON PRODUCT: NA. CORRECTIVE/PREVENTIVE ACTIONS: NA.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233456 FLEXOCRIN (2.5) 90CM DS19 SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL S.A. C0865346 612223

    Patients

    Seq Age Sex Outcome Treatment
    1 Other