BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD MEDICAL-BARDEX LUBRICATH FOLEY CATHETER TRAY SURESTEP FOLEY TRAN SYSTEM

    MDR report key: 5243494 · Received November 18, 2015

    Report

    Report Number
    MW5058022
    Event Type
    Other
    Date Received
    November 18, 2015
    Date of Event
    September 25, 2015
    Report Date
    November 18, 2015
    Manufacturer
    C.R. BARD, INC.
    Product Code
    KOD
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    BARD "SURESTEP FOLEY TRAY SYSTEM," WHICH CONTAINS LATEX, WAS ACCIDENTALLY USED ON A LATEX ALLERGIC PT PRIOR TO SURGERY. THE PT EXPERIENCED LESIONS ON HIS PENIS AND BLADDER PAIN AFTER THE PROCEDURE. THE PRODUCT LABELING HAS BEEN CHANGED, SO IT IS VERY DIFFICULT TO DIFFERENTIATE THE LATEX CONTAINING KIT FROM THE NON-LATEX CONTAINING KIT. THE NON-LATEX CONTAINING KIT HAS AN ADDITIONAL LABEL WITH THE ACRONYM NRL, WHICH IS NOT FAMILIAR TO NURSES. THE TEXT IS ALSO THE SAME COLOR AS THE REST OF THE PACKAGING. MORE IMPORTANTLY, THE KIT WHICH DOES CONTAIN LATEX, ONLY NOTES IT IN TINY FONT ON THE SIDE OF THE PACKAGE. THE TWO KITS ARE DIFFICULT TO DIFFERENTIATE AT A GLANCE. IN THE PAST, THERE WAS A LARGE ORANGE AREA THAT DENOTED THE PRESENCE OF LATEX, WHICH IS WHAT THE NURSES ARE USED TO SEEING. THIS LABELING ISSUE WAS ONE OF MANY ROOT CAUSES WHICH MAY HAVE PREVENTED A LATEX PRODUCT FROM REACHING THE PT, BUT IT WAS THE LAST LINE OF DEFENSE IN THIS CASE. WE WOULD LIKE THE BARD CORPORATION TO ADDRESS THEIR LABELING OF THE SURESTEP FOLEY TRAY SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765229 BARD MEDICAL-BARDEX LUBRICATH FOLEY CATHETER TRAY SURESTEP FOLEY TRAN SYSTEM UROLOGICAL CATHETER KOD C.R. BARD, INC. A899916

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR