BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL QUI+ UNDY 4/0 (1,5) 70CM HR22 (M)

    MDR report key: 3880717 · Received May 28, 2014

    Report

    Report Number
    2916714-2014-00412
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 28, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K031286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 24 UNOPENED POUCHES. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. ALL PACKS RECEIVED ARE TIGHT. TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE OEM. KNOT PULL TENSILE STRENGTH RESULTS BEFORE RELEASING THE PRODUCT FULFILLED OEM REQUIREMENTS. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THREAD BREAKS EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314182 SAFIL QUI+ UNDY 4/0 (1,5) 70CM HR22 (M) SYNTHETIC ABSORBABLE SUTURE GAM B. BRAUN SURGICAL S.A. C1046029 114055

    Patients

    Seq Age Sex Outcome Treatment
    1 Other