BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA?

    MDR report key: 3951106 · Received July 22, 2014

    Report

    Report Number
    2134265-2014-04270
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE DEVICE RETURNED WAS INSPECTED, ALL THE SEALS OF THE POUCH WERE FOUND SEALED, HOWEVER THREE COUPLES OF HOLES WERE FOUND AT THE PACKAGE, APPEARED TO BE STAPLE HOLES. A STAPLE WAS COMPARED OVER THE HOLES ENCOUNTERED AND THE HOLES MATCHED WITH THE STAPLE SIZE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STERILIZATION ISSUE OCCURRED. DURING UNPACKING OF THE FLEXIMA DEVICE, IT WAS NOTED THAT THERE WERE HOLES IN THE PACKAGING THROUGH THE STERILE FIELD. AS THERE WAS NO CONTACT WITH THE PATIENT, NO COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STERLIZATION ISSUE OCCURRED. DURING UNPACKING OF THE FLEXIMA¿ DEVICE, IT WAS NOTED THAT THERE WERE HOLES IN THE PACKAGING THROUGH THE STERILE FIELD. AS THERE WAS NO CONTACT WITH THE PATIENT, NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427671 FLEXIMA? TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001274020 16835378

    Patients

    Seq Age Sex Outcome Treatment
    1 Other