BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMELENE 4/0 (1.5) 90 CM 2XHR26 CV

    MDR report key: 3850361 · Received March 18, 2014

    Report

    Report Number
    2916714-2014-00153
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAW
    PMA / PMN Number
    K980703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MFG SITE EVAL: SAMPLES REC'D: 32 UNOPENED RACEPACKS. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OEM STOCK. THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES REC'D WAS TESTED AND THE RESULTS FULFILL THE REQUIREMENTS OF THE OEM. KNOT PULL TENSILE STRENGTH RESULTS CONDUCTED ON THE SAMPLE REC'D FULFIL OEM REQUIREMENTS. LINEAR PULL TENSILE STRENGTH OF THE SAMPLES REC'D WAS TESTED AND THE RESULTS FULFIL OEM REQUIREMENTS. NEEDLE ATTACHMENT OF THE SAMPLES REC'D WAS TESTED AND THE RESULTS FULFILL THE REQUIREMENTS OF THE OEM. REVIEWED THE BATCH MFG 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). ACTIONS ON PRODUCT: NOT APPLICABLE. CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). DURING 4 DIFFERENT OPERATIONS, THE THREADS CRACKED AT THE JUNCTURE BETWEEN NEEDLE AND THREAD. THIS INCIDENT OCCURRED IN THE PAST, HOWEVER, AT THE TIME, THE CLIENT ASSUMED A HANDLING MISTAKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159843 PRIMELENE 4/0 (1.5) 90 CM 2XHR26 CV SUTURE GAW B. BRAUN SURGICAL S.A. C2090907 113354V003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other