BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3941127 · Received April 25, 2014

    Report

    Report Number
    2916714-2014-00297
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 25, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE NOT MARKETED IN THE US; HOWEVER, SIMILAR DEVICE IS. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE CUSTOMER OBSERVED A DIFFERENT BEHAVIOR IN THE NEEDLES DRC10. WITH PREMILENE YOU CAN GRAB THE NEEDLE BETTER/SAFER WITH THE FORCEPS, AFTER PENETRATING THE TISSUE. OPTILENE NEEDLES DRC10 ARE DIFFERENT IN BEHAVIOR BY THE SAME APPLICATIONS WITH THE SAME INSTRUMENTS. THE NEEDLE NOTICEABLY HASN'T GOT A GOOD GRIP, IF YOU GRAB IT WITH THE FORCEPS. THE SAME TYPE OF THE NEEDLE HAS A DIFFERENT FEELING DURING HANDLING AND IT'S HARD TO GRAB. THE NEEDLE SLIPS THROUGH THE FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250720 OPTILENE 4/0 (1.5) 90CM 2XHR26 CV CARDIAC SUTURE GAT B. BRAUN SURGICAL S.A. C3090546 113392V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other