BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 1222512 · Received November 6, 2008

    Report

    Report Number
    2084725-2008-00730
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    JOHNSON & JOHNSON MEDICAL LTD.
    Product Code
    MED
    PMA / PMN Number
    K991487
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PATIENT WHO HAD ACINETOBACTERIA WAS BRONCHED AND THE DOCTOR USED THE SAME INSTRUMENT ON A SECOND PATIENT THREE HOURS LATER. THE INSTRUMENT WAS REPORTED TO HAVE BEEN CLEANED WITH CIDEX OPA PRIOR TO USE ON THE 2ND PATIENT. THIS COMPLAINT IS FOCUSED ON TH 2ND PATIENT WHO STAYED IN THE HOSPITAL AFTER THE PROCEDURE AND WAS PRESCRIBED TOBRAMYCIN AND COLYMYACIN FOR THE BACTERIA. THE 2ND PATIENT DIED ONE WEEK AFTER THE PROCEDURE. THE 2ND PATIENT HAD LUNG CANCER AND CUSTOMER STATED THAT THE BACTERIA IS NON-PATHOGENIC AND NOT THAT KIND OF ORGANISM THAT WOULD BE FATAL. IT WAS REPORTED THAT DEATH WAS DUE TO THE LUNG CANCER. THERE WERE NO REPORTS OF COMPLICATIONS WITH THE 1ST PATIENT. THE CUSTOMER IS WAITING FOR DNA RESULTS OF THE BACTERIA FOUND ON BOTH PATIENTS ONE AND TWO. SHE IS ALSO CONCERNED THAT MAY BE THE DOCTOR WAS THE ONE THAT MAY HAVE CONTAMINATED THE INSTRUMENT. CUSTOMER WILL GIVE US THE RESULT OF THE DNA. ASP CUSTOMER CARE REVIEWED WITH THE CUSTOMER THE TYPE OF BACTERIA THAT CIDEX OPA IS EFFECTIVE AGAINST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX OPA SOLUTION BIOCIDES SOLUTIONS (MED) MED JOHNSON & JOHNSON MEDICAL LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| H