BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUBRI-SIL I/C FOLEY TRAY

    MDR report key: 2829812 · Received October 29, 2012

    Report

    Report Number
    1018233-2012-01583
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Report Date
    June 5, 2012
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    MJC
    PMA / PMN Number
    K984136
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A CORRECTIVE ACTION TO AN OBSERVATION ON FDA FORM 483 DATED JULY 25, 2012 FOR BARD MEDICAL DIVISION. THE SAMPLE WAS NOT RETURNED FOR EVAL. AFTER REVIEWING THE MFG PROCESS, RAW MATERIAL, MACHINERY AND DEVICE HISTORY REVIEW, THERE WAS NOTHING FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE LABELING STATES: "STERILE: CONTENTS OF INNER WRAP ARE STERILE UNLESS PACKAGE HAS BEEN OPENED OR DAMAGED." AND THE INSTRUCTIONS FOR USE STATES: "VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT WAS RECEIVED WITH THE PACKAGE OPENED IN THE CIRCULATOR BUNDLE. THIS ISSUE WAS FOUND PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUBRI-SIL I/C FOLEY TRAY MJC PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGVJ2565

    Patients

    Seq Age Sex Outcome Treatment
    1