BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-MED CENTRAL VENOUS CATHETER

    MDR report key: 1510261 · Received October 15, 2009

    Report

    Report Number
    MW5013020
    Event Type
    Injury
    Date Received
    October 15, 2009
    Date of Event
    October 8, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A MULTI-MED CENTRAL VENOUS CATHETER KIT WAS ORDERED BY PHYSICIAN. THIS KIT CONTAINS A HEPARIN COATED CATHETER AS NOTED ON THE LABEL. PT HAS AN ALLERGY TO HEPARIN. THE CATHETER WAS INSERTED INTO THE PT. THE PT'S HEALTH DETERIORATED AND WAS TRANSFERRED TO A TERTIARY CARE CENTER THE NEXT DAY. HOSPITAL PERSONNEL CALLED THE COMPANY CONCERNED ABOUT THE SMALL PRINT ON THE PACKAGE LABEL INDICATING THE PRESENCE OF HEPARIN ON THE PRODUCT CATHETER AS WELL AS THE LACK OF ALERTS TO POTENTIAL ALLERGY. THE COMPANY REP STATED THE INFO THAT POINTS TO THE PRODUCT BEING CONTRAINDICATED IN PATIENTS WITH HEPARIN ALLERGY IS FOUND IN THE PACKAGE INSERT. THIS INSERT IS NOT FOUND INSIDE THE KIT, BUT IS PLACED INSIDE THE SHIPPING CONTAINER IN WHICH 10 KITS ARE PUT PRIOR TO SEALING FOR SHIPPING AND WOULD NOT NORMALLY ACCOMPANY THE KIT TO ITS POINT OF USE. INCIDENTALLY, ONLY THE PACKAGE INSERT FOR ALL 5 KITS IS PUT IN THE BOX. THE LABEL ON THE KIT UNDER "CONTENTS" LISTS THE CATHETER AND IN PARENTHESIS AN ASTERISK CONTAINED IN THE WORDING "ANTIMICROBIAL HEPARIN COATING". THIS ASTERISK DIRECTS THE USER TO A STATEMENT BELOW THE LIST OF CONTENTS WHICH READS "SEE PACKAGE INSERT FOR DETAILED INFO. READ ENCLOSED DRUG CIRCULARS". WHEN OPENED, THE ONLY DRUG CIRCULAR INSIDE IS ONE FOR LIDOCAINE INJECTION (ONE AMP OF LIDOCAINE INJ IS IN THE KIT). THERE IS NO ALERT OR WARNING ON THE PRODUCT ADDRESSING THE HEPARIN CONTRAINDICATION. HOWEVER, THERE IS A CAUTION STATEMENT ON THIS SAME LABEL STATING "BE ALERT TO ANY ADVERSE REACTION TO LIDOCAINE". THE PRODUCT LABEL ON THE KIT NEEDS TO ADDRESS THE CONTRAINDICATION USE IN HEPARIN ALLERGY IN A MORE VISIBLE MANNER. P.S. EDWARDS LIFESCIENCES LLC ALSO MAKES A SWAN-GANZ KIT WHOSE CATHETER IS HEPARIN COATED. HOWEVER, IT IS IN SMALL PRINT AND COULD VERY EASILY BE OVERLOOKED BY THE USER AT THE TIME OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-MED CENTRAL VENOUS CATHETER IV CATHETER DQO EDWARDS LIFESCIENCES M3720HKIC 58724021

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening