BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUORO-4 COIL STENT

    MDR report key: 2829811 · Received October 29, 2012

    Report

    Report Number
    1018233-2012-01584
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    March 22, 2011
    Report Date
    March 24, 2011
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    FAD
    PMA / PMN Number
    K823487
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR BARD MEDICAL DIVISION. RECEIVED ONE UNOPENED TRAY INCLUDING STENT, PUSH CATHETER, AND STENT CLAMP. VISUAL INSPECTION NOTED A DEPRESSION/TEAR IN THE (B)(4) LID CLOSE TO THE BOTTOM SEAL. THE TEAR APPEARS TO BE THE RESULT OF SOME TYPE OF EXTERNAL PRESSURE ON THE LID OVER THE STENT CLAMP ACTIVITY. IN ADDITION, IT WAS NOTED THAT THE TRAY WAS DAMAGED. IT APPEARED TO HAVE BEEN HIT FROM THE OUTSIDE TO THE INSIDE CAUSING A DEFORMATION. NO DEFECT WAS NOTED ON THE TRAY SEAL. THE TRAY WAS TESTED PER METHYLENE BLUE SEAL INTEGRITY DYE TEST AND DURING THIS TEST, THE UNIT LEAKED THROUGH THE TEAR. NO LEAKAGE WAS NOTED ON THE TRAY SEAL. THE DEVICE HISTORY RECORD WAS REVIEWED FINDING NO DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE STATE "FOR SINGLE USE ONLY. DO NOT RESTERILIZE. DO NOT USE IF THE PACKAGE OR PRODUCT IS DAMAGED". (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT JUST BEFORE USING THE PRODUCT, THE DOCTOR NOTICED THAT THE POUCH WAS PIERCED. ANOTHER UNIT WAS USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUORO-4 COIL STENT FAD PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGUI2100

    Patients

    Seq Age Sex Outcome Treatment
    1