BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER

    MDR report key: 9290431 · Received November 7, 2019

    Report

    Report Number
    1018233-2019-07124
    Event Type
    Injury
    Date Received
    November 7, 2019
    Report Date
    November 26, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    UDI-DI
    00801741074004
    PMA / PMN Number
    K910846
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED AS USER-RELATED. VISUAL INSPECTION NOTED TWO PHOTO SAMPLES WERE RECEIVED. THE EVENT INFERRED THAT ONCE THE PRODUCTS REACHED THE HOSPITAL, THE NURSES RELABELED THE PRODUCTS WITH THEIR OWN LABEL TO HELP IDENTIFY LATEX AND NON-LATEX PRODUCTS. VISUAL EVALUATION NOTED ONE OF THE PHOTO SAMPLES HAD ONE PRODUCT WITH THE "NON-NRL" LABEL ON IT PROPERLY RELABELED WITH A "NON-LATEX" STICKER. THE PHOTO ALSO SHOWED TWO SAMPLES THAT DID NOT HAVE THE "NON-NRL" LABEL WITH THE PROPER "THIS PRODUCT CONTAINS LATEX" STICKERS. THE OTHER PHOTO SAMPLE SHOWED A FOLEY TRAY WITHOUT THE "NON-NRL" LABEL IMPROPERLY RELABELED WITH A "NON-LATEX" STICKER. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "CAUTION THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INCIDENT LAST WEEK WHEN A LATEX KIT WAS INSERTED INTO THE PATIENT WHO HAD A LATEX ALLERGY. THE CENTRAL SUPPLY MANAGER AT THE HOSPITAL STATED THAT IT WAS DUE TO HUMAN ERROR ON A FEW DIFFERENT LEVELS. THE HOSPITAL STRUGGLED WITH BEING ABLE TO EASILY IDENTIFY THOSE KITS QUICKLY, BECAUSE BEFORE THE KITS THAT WERE LATEX FREE HAD "NRL" ON THE FRONT, BUT NOW THERE IS NOT AN EASY IDENTIFIER. PER ADDITIONAL INFORMATION RECEIVED FROM THE CENTRAL SUPPLY MANAGER ON 11OCT2019, THE HOSPITAL STATED THAT THE STAFF INCORRECTLY PLACED THE NON-LATEX STICKER ON THE KIT. THE SUPPLY MANAGER STATED THIS WAS ALLOWING TOO MUCH ROOM FOR HUMAN ERROR BY HAVING TO PLACE THE STICKERS ON THE KITS BECAUSE NURSING WAS HAVING A DIFFICULT TIME IDENTIFYING THE PRODUCTS. THE HOSPITAL ASKED IF BARD IS DOING ANYTHING TO ADDRESS IT. PER ADDITIONAL INFORMATION RECEIVED FROM THE CENTRAL SUPPLY MANAGER ON 16OCT2019, SHE CONFIRMED THAT THE CAUTION STATEMENT WAS ON THE SIDE OF THE KIT. THE PATIENT RECEIVED MEDICATION IN THE HOSPITAL FOR THE LATEX REACTION. THE NAME OF THE MEDICATION WAS CURRENTLY NOT KNOWN.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED AS USER-RELATED. VISUAL INSPECTION NOTED TWO PHOTO SAMPLES WERE RECEIVED. THE EVENT INFERRED THAT ONCE THE PRODUCTS REACHED THE HOSPITAL, THE NURSES RELABELED THE PRODUCTS WITH THEIR OWN LABEL TO HELP IDENTIFY LATEX AND NON-LATEX PRODUCTS. VISUAL EVALUATION NOTED ONE OF THE PHOTO SAMPLES HAD ONE PRODUCT WITH THE "NON-NRL" LABEL ON IT PROPERLY RELABELED WITH A "NON-LATEX" STICKER. THE PHOTO ALSO SHOWED TWO SAMPLES THAT DID NOT HAVE THE "NON-NRL" LABEL WITH THE PROPER "THIS PRODUCT CONTAINS LATEX" STICKERS. THE OTHER PHOTO SAMPLE SHOWED A FOLEY TRAY WITHOUT THE "NON-NRL" LABEL IMPROPERLY RELABELED WITH A "NON-LATEX" STICKER. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "CAUTION THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INCIDENT LAST WEEK WHEN A LATEX KIT WAS INSERTED INTO THE PATIENT WHO HAD A LATEX ALLERGY. THE CENTRAL SUPPLY MANAGER AT THE HOSPITAL STATED THAT IT WAS DUE TO HUMAN ERROR ON A FEW DIFFERENT LEVELS. THE HOSPITAL STRUGGLED WITH BEING ABLE TO EASILY IDENTIFY THOSE KITS QUICKLY, BECAUSE BEFORE THE KITS THAT WERE LATEX FREE HAD "NRL" ON THE FRONT, BUT NOW THERE IS NOT AN EASY IDENTIFIER. PER ADDITIONAL INFORMATION RECEIVED FROM THE CENTRAL SUPPLY MANAGER ON 11OCT2019, THE HOSPITAL STATED THAT THE STAFF INCORRECTLY PLACED THE NON-LATEX STICKER ON THE KIT. THE SUPPLY MANAGER STATED THIS WAS ALLOWING TOO MUCH ROOM FOR HUMAN ERROR BY HAVING TO PLACE THE STICKERS ON THE KITS BECAUSE NURSING WAS HAVING A DIFFICULT TIME IDENTIFYING THE PRODUCTS. THE HOSPITAL ASKED IF BARD IS DOING ANYTHING TO ADDRESS IT. PER ADDITIONAL INFORMATION RECEIVED FROM THE CENTRAL SUPPLY MANAGER ON 16OCT2019, SHE CONFIRMED THAT THE CAUTION STATEMENT WAS ON THE SIDE OF THE KIT. THE PATIENT RECEIVED MEDICATION IN THE HOSPITAL FOR THE LATEX REACTION. THE NAME OF THE MEDICATION WAS CURRENTLY NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086090 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER SURESTEP FOLEY KIT EZC C.R. BARD, INC. (COVINGTON) -1018233 A899914 UNK 00801741074004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention