BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAFILON BLUE 5/0 (1) 45CM DSMP13 (M)

    MDR report key: 4213901 · Received October 6, 2014

    Report

    Report Number
    2916714-2014-00776
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    August 27, 2014
    Report Date
    October 6, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAR
    PMA / PMN Number
    K990090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON: (B)(4) 2014. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 20 UNOPENED POUCHES. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE AE NO UNITS IN OEM STOCK. WE HAVE TESTED THE NEEDLE ATTACHMENT OF THE SAMPLES RECEIVED AND THE RESULTED FULFILLED 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 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 DETACHES EASILY FROM NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625062 DAFILON BLUE 5/0 (1) 45CM DSMP13 (M) SYNTHETIC SUTURE GAR B. BRAUN SURGICAL S.A. C0936090 613216

    Patients

    Seq Age Sex Outcome Treatment
    1 Other