BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAFILON BLUE 3/0 (2) 75CM DS39

    MDR report key: 3850438 · Received March 18, 2014

    Report

    Report Number
    2916714-2014-00165
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    January 14, 2014
    Report Date
    March 18, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAR
    PMA / PMN Number
    K990090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MFG SITE EVAL: SAMPLES RECEIVED: 31 UNOPENED POUCHES. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE 12 UNITS IN OEM STOCK. NEEDLE ATTACHMENT OF THE SAMPLES RECEIVED WAS TESTED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE OEM. REVIEW THE BATCH MFG RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. THE COMPLAINT IS JUSTIFIED FOR ISOLATED DETACHED NEEDLES, BUT THE CONCLUSION IS NOT CORRESPONDING ACCORDING TO THE RESULTS OF THE SAMPLES TESTED. 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). NEEDLE AND THREAD DETACHMENT. THIS HAS HAPPENED IN DIFFERENT GYN PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161343 DAFILON BLUE 3/0 (2) 75CM DS39 NON-ABSORBABLE SUTURE GAR B. BRAUN SURGICAL S.A. C0932540 613263

    Patients

    Seq Age Sex Outcome Treatment
    1 Other